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Review Article| Volume 29, ISSUE 1, P33-50, January 2013

Ventilator-associated Complications, Including Infection-related Complications

The Way Forward
Published:November 07, 2012DOI:https://doi.org/10.1016/j.ccc.2012.10.004

      Keywords

      Key points

      • Optimizing the care of mechanically ventilated patients is an important goal for health care providers and hospital administrators.
      • An easily acquired and reliable marker of medical quality has been elusive for this patient population.
      • Ventilator-associated complications (VACs) represent a potential solution to this problem. VACs can be easily monitored for and obtained, being defined by changes in oxygenation and/or positive end-expiratory pressure.
      • The potential also exists to track VACs automatically using hospital informatics systems.
      • It is important to first establish that VACs are preventable, and not simply markers of disease severity, to use them as true markers of medical quality for purposes of interinstitutional comparison and reimbursement.

      Introduction

      Ventilator-associated pneumonia (VAP) is one of the most common infections occurring in mechanically ventilated patients requiring antibiotic administration. Because VAP has historically been associated with excess morbidity and mortality in critically ill patients, it has been used as an overall marker of the quality of care associated with mechanical ventilation. Although recent studies have challenged the association between VAP and increased mortality, there is greater consensus that VAP is associated with prolonged durations of mechanical ventilation, increased intensive care unit (ICU) length of stay, and increased hospital costs.
      • Nguile-Makao M.
      • Zahar J.R.
      • Francais A.
      • et al.
      Attributable mortality of ventilator-associated pneumonia: respective impact of main characteristics at ICU admission and VAP onset using conditional logistic regression and multi-state models.
      • Shorr A.F.
      • Zilberberg M.D.
      • Kollef M.
      Cost-effectiveness analysis of a silver-coated endotracheal tube to reduce the incidence of ventilator-associated pneumonia.
      • Warren D.K.
      • Shukla S.J.
      • Olsen M.A.
      • et al.
      Outcome and attributable cost of ventilator-associated pneumonia among intensive care unit patients in a suburban medical center.
      • Kollef M.H.
      • Hamilton C.W.
      • Ernst F.R.
      Economic impact of ventilator-associated pneumonia in a large matched cohort.
      Bekaert and colleagues
      • Bekaert M.
      • Timsit J.F.
      • Vansteelandt S.
      • et al.
      Attributable mortality of ventilator-associated pneumonia: a reappraisal using causal analysis.
      estimated that 4.4% of the deaths in the ICU on day 30 and 5.9% on day 60 are attributable to VAP. As opposed to previous studies, these investigators simultaneously accounted for the time of acquiring VAP, loss to follow-up after ICU discharge, and the existence of complex feedback relations between VAP and disease severity. Kollef and colleagues
      • Kollef M.H.
      • Hamilton C.W.
      • Ernst F.R.
      Economic impact of ventilator-associated pneumonia in a large matched cohort.
      showed, in a matched cohort, that patients with VAP had longer mean durations of mechanical ventilation (21.8 vs 10.3 days), ICU stay (20.5 vs 11.6 days), hospitalization (32.6 vs 19.5 days), and costs ($99,598 vs $59,770) than patients without VAP.
      One of the major clinical issues related to the management of mechanically ventilated patients in the ICU is the increasing occurrence of infections, including VAP, caused by multidrug-resistant (MDR) or extremely drug-resistant (XDR) pathogens.
      • Arias C.A.
      • Murray B.E.
      Antibiotic-resistant bugs in the 21st century–a clinical super-challenge.
      The available evidence suggests that the overall prevalence of nosocomial infections attributed to MDR and XDR pathogens, as well as the global use of antibiotics in the hospital setting, is not diminishing despite local and national efforts to curb these infections.
      • Chung R.
      • Song J.-H.
      • Kim S.H.
      • et al.
      High prevalence of multidrug-resistant non-fermenters in hospital-acquired pneumonia in Asia.
      • Kallen A.J.
      • Hidron A.I.
      • Patel J.
      • et al.
      Multidrug resistance among gram-negative pathogens that caused healthcare-associated infections reported to the National Healthcare Safety Network, 2006-2008.
      Disorders such as tracheobronchitis and sepsis, which often are diagnosed in the presence of nosocomial pneumonia, seem to be more common, contributing, at least in part, to the increasing use of antibiotics in the ICU.
      • Vincent J.L.
      • Rello J.
      • Marshall J.
      • et al.
      International study of the prevalence and outcomes of infection in intensive care units.
      VAP is recognized to be among the most common infections associated with MDR and XDR bacteria including Pseudomonas aeruginosa, Acinetobacter species, and Klebsiella pneumonia carbapenemase–containing Enterobacteriaceae.
      • Kallen A.J.
      • Hidron A.I.
      • Patel J.
      • et al.
      Multidrug resistance among gram-negative pathogens that caused healthcare-associated infections reported to the National Healthcare Safety Network, 2006-2008.
      • Vincent J.L.
      • Rello J.
      • Marshall J.
      • et al.
      International study of the prevalence and outcomes of infection in intensive care units.
      • Kollef K.E.
      • Schramm G.E.
      • Wills A.R.
      • et al.
      Predictors of 30-day mortality and hospital costs in patients with ventilator-associated pneumonia attributed to potentially antibiotic-resistant gram-negative bacteria.
      • Centers for Disease Control and Prevention (CDC)
      Detection of Enterobacteriaceae isolates carrying metallo-beta-lactamase - United States, 2010.
      • Cantón R.
      • Akóva M.
      • Carmeli Y.
      • et al.
      Rapid evolution and spread of carbapenemases among Enterobacteriaceae in Europe.
      • Viau R.A.
      • Hujer A.M.
      • Marshall S.H.
      • et al.
      “Silent” Dissemination of Klebsiella pneumoniae isolates bearing K. pneumoniae carbapenemase in a long-term care facility for children and young adults in northeast Ohio.
      • Lee Y.T.
      • Kuo S.C.
      • Yang S.P.
      • et al.
      Impact of appropriate antimicrobial therapy on mortality associated with Acinetobacter baumannii bacteremia: relation to severity of infection.
      • Sandiumenge A.
      • Rello J.
      Ventilator-associated pneumonia caused by ESKAPE organisms: cause, clinical features, and management.
      • Ferrer R.
      • Artigas A.
      • Suarez D.
      • et al.
      Effectiveness of treatments for severe sepsis: a prospective, multicenter, observational study.
      • Boucher H.
      • Talbot G.H.
      • Bradley J.S.
      • et al.
      Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America.
      • Kollef M.H.
      Broad-spectrum antimicrobials and the treatment of serious bacterial infections: getting it right up front.
      • Johnson M.T.
      • Reichley R.
      • Hoppe-Bauer J.
      • et al.
      Impact of previous antibiotic therapy on outcome of Gram-negative severe sepsis.
      The recent recognition of Enterobacteriaceae containing the NDM1 gene in multiple continents raises the possibility of endemic spread of common enteric bacteria possessing resistance to all currently available antibacterial agents.
      • Centers for Disease Control and Prevention (CDC)
      Detection of Enterobacteriaceae isolates carrying metallo-beta-lactamase - United States, 2010.
      The major concern related to the emergence of MDR and XDR pathogens as a cause of VAP is the inability to empirically treat these infections when they are initially suspected. Inappropriate initial antimicrobial therapy, defined as an antimicrobial regimen that lacks in vitro activity against the isolated organism(s) responsible for the infection, has been associated with excess mortality in patients with serious infections, including VAP and severe sepsis.
      • Kollef K.E.
      • Schramm G.E.
      • Wills A.R.
      • et al.
      Predictors of 30-day mortality and hospital costs in patients with ventilator-associated pneumonia attributed to potentially antibiotic-resistant gram-negative bacteria.
      • Ferrer R.
      • Artigas A.
      • Suarez D.
      • et al.
      Effectiveness of treatments for severe sepsis: a prospective, multicenter, observational study.
      • Kollef M.H.
      • Sherman G.
      • Ward S.
      • et al.
      Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients.
      • Dhainaut J.F.
      • Laterre P.F.
      • LaRosa S.P.
      • et al.
      The clinical evaluation committee in a large multicenter phase 3 trial of drotrecogin alfa (activated) in patients with severe sepsis (PROWESS): role, methodology, and results.
      • Garnacho-Montero J.
      • Garcia-Garmendia J.L.
      • Barrero-Almodovar A.
      • et al.
      Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis.
      • Harbarth S.
      • Garbino J.
      • Pugin J.
      • et al.
      Inappropriate initial antimicrobial therapy and its effect on survival in a clinical trial of immunomodulating therapy for severe sepsis.
      This is largely related to increasing bacterial resistance to antibiotics as a result of their greater use and the limited availability of newer agents.
      • Arias C.A.
      • Murray B.E.
      Antibiotic-resistant bugs in the 21st century–a clinical super-challenge.
      • Boucher H.
      • Talbot G.H.
      • Bradley J.S.
      • et al.
      Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America.
      Escalating rates of antimicrobial resistance lead many clinicians to empirically treat critically ill patients with presumed infection with a combination of broad-spectrum antibiotics, which can further perpetuate the cycle of increasing resistance.
      • Boucher H.
      • Talbot G.H.
      • Bradley J.S.
      • et al.
      Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America.
      Inappropriate initial antimicrobial therapy can, conversely, lead to treatment failures and adverse patient outcomes.
      • Kollef M.H.
      Broad-spectrum antimicrobials and the treatment of serious bacterial infections: getting it right up front.
      • Garnacho-Montero J.
      • Garcia-Garmendia J.L.
      • Barrero-Almodovar A.
      • et al.
      Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis.
      Moreover, the limited diversity of available antimicrobial agents has created a clinical situation in which patients are repetitively exposed to the same class of antibiotic, or, in some circumstances, the same agent, resulting in an increased risk of treatment failure and mortality.
      • Johnson M.T.
      • Reichley R.
      • Hoppe-Bauer J.
      • et al.
      Impact of previous antibiotic therapy on outcome of Gram-negative severe sepsis.
      Therefore, the broader concern for all intensivists is how to limit the emergence and spread of MDR/XDR pathogens, as well as the infections associated with these pathogens.
      A recent international point prevalence ICU study found the lungs to be the most common site of infection, accounting for 64% of infections, followed by the abdomen (20%), the bloodstream (15%), and the renal tract/genitourinary system (14%).
      • Vincent J.L.
      • Rello J.
      • Marshall J.
      • et al.
      International study of the prevalence and outcomes of infection in intensive care units.
      Despite important geographic variations, Enterococcus faecium, Staphylococcus aureus, K pneumoniae, Acinetobacter baumannii, P aeruginosa, and Enterobacter species (ESKAPE) pathogens constitute more than 80% of VAP episodes.
      • Vincent J.L.
      • Rello J.
      • Marshall J.
      • et al.
      International study of the prevalence and outcomes of infection in intensive care units.
      • Sandiumenge A.
      • Rello J.
      Ventilator-associated pneumonia caused by ESKAPE organisms: cause, clinical features, and management.
      Their clinical importance relies on their virulence and ability to develop mechanisms conferring decreased susceptibility to antimicrobials, increasing inappropriate therapy and negatively affecting the outcomes of patients in the ICU. These studies highlight the overall importance of pulmonary infections as a major cause of morbidity and antibiotic use in the ICU. However, given concerns about current diagnostic criteria for VAP, especially for assessing the clinical impact of infection prevention or quality-improvement programs on patient outcomes, other indicators of ICU care quality have been explored.
      • Halpern N.A.
      • Hale K.E.
      • Sepkowitz K.A.
      • et al.
      A world without ventilator-associated pneumonia: time to abandon surveillance and deconstruct the bundle.
      • Kollef M.H.
      Prevention of ventilator-associated pneumonia or ventilator-associated complications: a worthy, yet challenging, goal.

      Problematic definition of VAP

      Clinical criteria are known to be nonspecific for the diagnosis of nosocomial pneumonia, including VAP. Clinical findings such as fever, leukocytosis, and purulent secretions occur with other noninfectious pulmonary conditions such as atelectasis, pulmonary contusion, and acute respiratory distress syndrome (ARDS), and therefore lack specificity for the diagnosis of VAP.
      • Morrow L.E.
      • Kollef M.H.
      Recognition and prevention of nosocomial pneumonia in the intensive care unit and infection control in mechanical ventilation.
      • Tejerina E.
      • Esteban A.
      • Fernandez-Segoviano P.
      • et al.
      Accuracy of clinical definitions of ventilator-associated pneumonia: comparison of autopsy findings.
      • Rea-Neto A.
      • Youssef N.C.
      • Tuche F.
      • et al.
      Diagnosis of ventilator-associated pneumonia: a systematic review of the literature.
      • Vincent J.L.
      • de Souza Barros D.
      • Cianferoni S.
      Diagnosis, management, and prevention of ventilator-associated pneumonia.
      Chest radiographs can similarly be nonspecific for the diagnosis of nosocomial pneumonia. Wunderink and colleagues
      • Wunderink R.G.
      • Woldenberg L.S.
      • Zeiss J.
      • et al.
      The radiologic diagnosis of autopsy-proven ventilator-associated pneumonia.
      found that no roentgenographic sign correlated well with the presence of pneumonia in mechanically ventilated patients. The presence of air bronchograms was the only roentgenographic sign that correlated with autopsy-verified pneumonia, correctly predicting 64% of cases. The most frequently used clinical diagnosis of VAP has traditionally required the presence of a new or progressive consolidation on chest radiology plus at least 2 of the following clinical criteria: fever greater than 38°C, leukocytosis or leukopenia, and purulent secretions. This definition has been supported by several medical specialty groups,
      • Pingleton S.K.
      • Fagon J.Y.
      • Leeper Jr., K.V.
      Patient selection for clinical investigation of ventilator-associated pneumonia. Criteria for evaluating diagnostic techniques.
      • American Thoracic Society; Infectious Diseases Society of America
      Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia.
      despite the lack of specificity of these criteria.
      • Tejerina E.
      • Esteban A.
      • Fernandez-Segoviano P.
      • et al.
      Accuracy of clinical definitions of ventilator-associated pneumonia: comparison of autopsy findings.
      • Rea-Neto A.
      • Youssef N.C.
      • Tuche F.
      • et al.
      Diagnosis of ventilator-associated pneumonia: a systematic review of the literature.
      • Vincent J.L.
      • de Souza Barros D.
      • Cianferoni S.
      Diagnosis, management, and prevention of ventilator-associated pneumonia.
      • Wunderink R.G.
      • Woldenberg L.S.
      • Zeiss J.
      • et al.
      The radiologic diagnosis of autopsy-proven ventilator-associated pneumonia.
      The Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) has established a clinical definition for the presence of probable nosocomial pneumonia including VAP.

      Centers for Disease Control and Prevention: National Nosocomial Infections Surveillance System (NNIS). Available at: http://www.cdc.gov/ncidod/dhqp/nnis.html. Accessed March 7, 2012.

      However, these diagnostic criteria have not been validated and at least 1 study found that decision making using these criteria was not accurate, potentially resulting in the withholding of antibiotics in 16% of patients diagnosed with VAP by bronchoalveolar lavage (BAL).
      • Miller P.R.
      • Johnson J.C.
      • Karchmer T.
      • et al.
      National nosocomial infection surveillance system: from benchmark to bedside in trauma patients.
      We recently compared the observed rates of VAP when using the CDC/NHSN surveillance method versus the American College of Chest Physicians (ACCP) clinical criteria.
      • Skrupky L.
      • McConnell K.
      • Dallas J.
      • et al.
      A comparison of ventilator-associated pneumonia rates as identified according to National Healthcare Safety Network (NHSN) and American College of Chest Physicians (ACCP) Criteria.
      Over 1 year, 2060 patients required mechanical ventilation for greater than 24 hours and were prospectively evaluated. Of these, 83 patients (4%) had VAP according to the ACCP criteria, compared with 12 patients (0.6%) using the CDC/NHSN surveillance method. The corresponding rates of VAP were 8.5 versus 1.2 cases per 1000 ventilator days, respectively. Agreement of the 2 sets of criteria was poor (κ statistic, 0.26). Quantitative lower respiratory tract cultures were positive in 88% of patients in the ACCP group and 92% in the NHSN group.
      • Skrupky L.
      • McConnell K.
      • Dallas J.
      • et al.
      A comparison of ventilator-associated pneumonia rates as identified according to National Healthcare Safety Network (NHSN) and American College of Chest Physicians (ACCP) Criteria.
      Others have noted that surveillance rates of VAP are decreasing, whereas clinical diagnoses of VAP and tracheobronchitis, as well as antibiotic prescribing, remain prevalent.
      • Klompas M.
      Is a ventilator-associated pneumonia rate of zero really possible?.
      External reporting pressures may be encouraging stricter interpretation of subjective signs that can cause an artifactual lowering of VAP rates. The result is that it is almost impossible to disentangle the relative contribution of quality-improvement efforts in the ICU versus surveillance effects as explanations for the currently observed low VAP rates.
      • Klompas M.
      Is a ventilator-associated pneumonia rate of zero really possible?.
      Given the limitations of clinical criteria for establishing the diagnosis of VAP, alternative methods have been pursued. Torres and colleagues
      • Torres A.
      • Fabregas N.
      • Ewig S.
      • et al.
      Sampling methods for ventilator-associated pneumonia: validation using different histologic and microbiological references.
      used quantitative cultures of respiratory specimens obtained by BAL, protected BAL (pBAL), protected specimen brush, and tracheobronchial aspirate (TBA), which were compared with histology of lung biopsy samples to establish the diagnosis of VAP. Sensitivities for the diagnosis of VAP ranged from 16% to 37% when only histologic reference tests were used, whereas specificity ranged from 50% to 77%. When lung histology of guided or blind specimens and microbiology of lung tissue were combined, all quantitative diagnostic techniques achieved higher, but still limited, diagnostic yields (sensitivity 43%–83%; specificity 67%–91%).
      • Torres A.
      • Fabregas N.
      • Ewig S.
      • et al.
      Sampling methods for ventilator-associated pneumonia: validation using different histologic and microbiological references.
      Similar diagnostic accuracy has been shown by other investigators using histologic criteria as a reference standard, suggesting that quantitative cultures of lower respiratory secretions may be of limited value.
      • Tejerina E.
      • Esteban A.
      • Fernandez-Segoviano P.
      • et al.
      Accuracy of clinical definitions of ventilator-associated pneumonia: comparison of autopsy findings.
      • Balthazar A.B.
      • Von N.A.
      • De Capitani E.M.
      • et al.
      Diagnostic investigation of ventilator-associated pneumonia using bronchoalveolar lavage: comparative study with a postmortem lung biopsy.
      • Torres A.
      • el-Ebiary M.
      • Padró L.
      • et al.
      Validation of different techniques for the diagnosis of ventilator-associated pneumonia. Comparison with immediate postmortem pulmonary biopsy.
      • Torres A.
      • El-Ebiary M.
      • Fábregas N.
      • et al.
      Value of intracellular bacteria detection in the diagnosis of ventilator associated pneumonia.
      • Kirtland S.H.
      • Corley D.E.
      • Winterbauer R.H.
      • et al.
      The diagnosis of ventilator-associated pneumonia: a comparison of histologic, microbiologic, and clinical criteria.
      • Marquette C.H.
      • Copin M.C.
      • Wallet F.
      • et al.
      Diagnostic tests for pneumonia in ventilated patients: prospective evaluation of diagnostic accuracy using histology as a diagnostic gold standard.
      • Papazian L.
      • Autillo-Touati A.
      • Thomas P.
      • et al.
      Diagnosis of ventilator-associated pneumonia: an evaluation of direct examination and presence of intracellular organisms.
      • Rouby J.J.
      • Rossignon M.D.
      • Nicolas M.H.
      • et al.
      A prospective study of protected bronchoalveolar lavage in the diagnosis of nosocomial pneumonia.
      • Fàbregas N.
      • Ewig S.
      • Torres A.
      • et al.
      Clinical diagnosis of ventilator associated pneumonia revisited: comparative validation using immediate post-mortem lung biopsies.
      To simplify the technical requirements for establishing a microbiologic diagnosis of VAP, Riaz and colleagues
      • Riaz O.J.
      • Malhotra A.K.
      • Aboutanos M.B.
      • et al.
      Bronchoalveolar lavage in the diagnosis of ventilator-associated pneumonia: to quantitate or not, that is the question.
      compared nonquantitative and quantitative respiratory secretion cultures for the diagnosis of VAP. These investigators found that nonquantitative culture of BAL was good at ruling out the presence of VAP but was poor at establishing the presence of VAP because of the low specificity of the test. Despite the limited overall accuracy of quantitative lower respiratory tract cultures for the diagnosis of VAP, the clinical use of such cultures has been associated with less overall antibiotic use,
      • Fagon J.Y.
      • Chastre J.
      • Wolff M.
      • et al.
      Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial.
      • Shorr A.F.
      • Sherner J.H.
      • Jackson W.L.
      • et al.
      Invasive approaches to the diagnosis of ventilator-associated pneumonia: a meta-analysis.
      • Ibrahim E.H.
      • Ward S.
      • Sherman G.
      • et al.
      Experience with a clinical guideline for the treatment of ventilator-associated pneumonia.
      • Dellit T.H.
      • Chan J.D.
      • Skerrett S.J.
      • et al.
      Development of a guideline for the management of ventilator-associated pneumonia based on local microbiologic findings and impact of the guideline on antimicrobial use practices.
      which presumably results from clinicians having greater confidence in ruling out VAP with negative quantitative culture results. Similar reductions in the duration of antibiotic therapy prescribed for clinically suspected VAP have been shown using serum procalcitonin thresholds, Clinical Pulmonary Infection Score (CPIS) values, and targeted protocols.
      • Bouadma L.
      • Luyt C.E.
      • Tubach F.
      • et al.
      Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial.
      • Stolz D.
      • Smyrnios N.
      • Eggimann P.
      • et al.
      Procalcitonin for reduced antibiotic exposure in ventilator-associated pneumonia: a randomised study.
      • Micek S.T.
      • Ward S.
      • Fraser V.J.
      • et al.
      A randomized controlled trial of an antibiotic discontinuation policy for clinically suspected ventilator-associated pneumonia.
      • Singh N.
      • Rogers P.
      • Atwood C.W.
      • et al.
      Short-course empiric antibiotic therapy for patients with pulmonary infiltrates in the intensive care unit. A proposed solution for indiscriminate antibiotic prescription.
      Given that VAP surveillance is time consuming, potentially less accurate than clinical/microbiologic criteria,
      • Miller P.R.
      • Johnson J.C.
      • Karchmer T.
      • et al.
      National nosocomial infection surveillance system: from benchmark to bedside in trauma patients.
      • Skrupky L.
      • McConnell K.
      • Dallas J.
      • et al.
      A comparison of ventilator-associated pneumonia rates as identified according to National Healthcare Safety Network (NHSN) and American College of Chest Physicians (ACCP) Criteria.
      and the use of quantitative lower respiratory tract cultures for the establishment of VAP is not universally performed, the CDC Epicenters Program (CDC-PEP) has recently supported efforts to shift ICU surveillance away from VAP. Instead, the CDC-PEP has focused on the occurrence of complications in general that might circumvent the VAP definition's subjectivity and inaccuracy, facilitate electronic assessment, make interfacility comparisons more meaningful, and encourage broader prevention strategies. Ventilator-associated complications (VACs) was selected as a more general marker and was defined by sustained increases in patients' ventilator settings after a period of stable or decreasing support (Box 1).
      Criteria for VACs, infection-related VACs (IVACs), possible VAP, and probable VAP proposed by the CDC-PEPa

        VAC

      • Patient has a baseline period of stability or improvement on the ventilator, defined by 2 or more calendar days of stable or decreasing Fio2 or PEEP. Baseline Fio2 and PEEP are defined by the minimum daily Fio2 or PEEP measurement during the period of stability or improvement.
      • After a period of stability or improvement on the ventilator, the patient has at least 1 of the following indicators of worsening oxygenation:
        • 1.
          Minimum daily Fio2 values increase greater than or equal to 0.20 (20 points) more than baseline and remain equal to or more than that increased level for 2 or more calendar days
        • 2.
          Minimum daily PEEP values increase greater than or equal to 3 cm H2O more than baseline and remain equal to or more than that increased level for 2 or more calendar days

        IVAC

      • On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria:
        • 1.
          Temperature greater than 38°C or less than 36°C, or white blood cell count greater than or equal to 12,000 cells/mm3 or less than or equal to 4000 cells/mm3
        • 2.
          A new antimicrobial agent(s) is started, and is continued for greater than or equal to 4 calendar days

        Possible VAP

      • On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, 1 of the following criteria is met:
        • 1.
          Purulent respiratory secretions (from 1 or more specimen collections)
          • a.
            Defined as secretions from the lungs, bronchi, or trachea that contain more than 25 neutrophils and less than 10 squamous epithelial cells per low-power field
          • b.
            If the laboratory reports semiquantitative results, those results must be equivalent to the quantitative thresholds presented earlier
        • 2.
          Positive culture (qualitative, semiquantitative, or quantitative) of sputum, endotracheal aspirate, BAL, lung tissue, or protected specimen brushing

        Probable VAP

      • On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, 1 of the following criteria is met:
        • 1.
          Purulent respiratory secretions (from 1 or more specimen collections and defined as for possible VAP)
        • And 1 of the following:
          • a.
            Positive culture of endotracheal aspirate, greater than or equal to 105 CFU/mL, or equivalent semiquantitative result
          • b.
            Positive culture of BAL, greater than or equal to 104 CFU/mL, or equivalent semiquantitative result
          • c.
            Positive culture of lung tissue, greater than or equal to 104 CFU/mL, or equivalent semiquantitative result
          • d.
            Positive culture of protected specimen brush, greater than or equal to 103 CFU/mL, or equivalent semiquantitative result
      • 2.
        One of the following (without requirement for purulent respiratory secretions):
        • a.
          Positive pleural fluid culture (specimen obtained during thoracentesis or initial placement of chest tube and not from an indwelling chest tube)
        • b.
          Positive lung histopathology
        • c.
          Positive diagnostic test for Legionella spp
        • d.
          Positive diagnostic test on respiratory secretions for influenza virus, respiratory syncytial virus, adenovirus, parainfluenza virus
      Abbreviations: CFU, colony-forming units; Fio2, fraction of inspired oxygen; PEEP, positive end-expiratory pressure.
      a Note that only VAC and IVAC are intended for public reporting.
      The use of VAC as an outcome predictor was examined in a recent CDC-PEP study of 597 mechanically ventilated patients.
      • Klompas M.
      • Khan Y.
      • Kleinman K.
      • et al.
      Multicenter evaluation of a novel surveillance paradigm for complications of mechanical ventilation.
      These investigators found that 9.3% of their study population developed VAP (8.8 per 1000 ventilator days) whereas 23% had a VAC (21.2 per 1000 ventilator days). Compared with matched controls, both VAP and VAC prolonged days to extubation (5.8, 95% confidence interval [CI] 4.2–8.0 and 6.0, 95% CI 5.1–7.1 respectively), days to ICU discharge (5.7, 95% CI 4.2–7.7 and 5.0, 95% CI 4.1–5.9), and days to hospital discharge (4.7, 95% CI 2.6–7.5 and 3.0, 95% CI 2.1–4.0). VAC was associated with increased mortality (odds ratio [OR] 2.0, 95% CI 1.3–3.2) but VAP was not (OR 1.1, 95% CI 0.5–2.4). VAC assessment was also faster (mean 1.8 minutes vs 39 minutes per patient). Both VAP and VAC events were predominantly attributable to pneumonia, pulmonary edema, ARDS, and atelectasis. The investigators concluded that screening for VAC captures a similar set of complications to traditional VAP surveillance but is faster, more objective, and potentially a superior predictor of clinical outcomes.
      Building on their experience with VAC, the CDC-PEP has begun to evaluate a new streamlined surveillance definition for VAP (sVAP) (Table 1) based on their experience with VAC. The same investigators retrospectively compared surveillance time, reproducibility, and outcomes for streamlined versus conventional surveillance definitions of VAP among medical and surgical patients on mechanical ventilation in 3 university hospitals.
      • Klompas M.
      • Kleinman K.
      • Khan Y.
      • et al.
      Rapid and reproducible surveillance for ventilator-associated pneumonia.
      Application of the streamlined definition was faster (mean 3.5 minutes vs 39.0 minutes per patient) and more objective than the conventional definition. On multivariate analysis, the streamlined definition predicted increases in ventilator days, intensive care days, and hospital mortality as effectively as conventional surveillance. Although sVAP does not necessarily reflect the presence of bacterial pneumonia, it is hoped that this marker will allow quality-improvement efforts to be more accurately assessed across time periods and institutions compared with the traditional use of VAP as a quality indicator.
      • Uçkay I.
      • Ahmed Q.A.
      • Sax H.
      • et al.
      Ventilator-associated pneumonia as a quality indicator for patient safety?.
      However, neither VAC or sVAP have been evaluated in terms of potentially modifying antibiotic consumption or reducing the emergence of antibiotic-resistant bacteria in the ICU setting.
      Table 1Comparison of conventional and streamlined surveillance definitions for VAP
      Conventional DefinitionStreamlined Definition
      RadiologyTwo or more serial chest radiographs with at least 1 of the following:Two or more serial chest radiographs with at least 1 of the following:
      • 1.
        New or progressive and persistent infiltrate
      • 1.
        New or progressive and persistent infiltrate
      • 2.
        Consolidation
      • 2.
        Consolidation
      • 3.
        Cavitation
      • 3.
        Cavitation
      Systemic signs (at least 1)
      • 1.
        Fever (>38°C or >100.4°F)
      • 1.
        Fever (>38°C or >100.4°F)
      • 2.
        Leukopenia (<4000 WBC/mm3) or leukocytosis (≥12 000 WBC/mm3)
      • 2.
        Leukopenia (<4000 WBC/mm3) or leukocytosis (≥12 000 WBC/mm3)
      • 3.
        For adults ≥70 years old, altered mental status with no other recognized cause
      Pulmonary signs (at least 2)
      • 1.
        New onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
      • 1.
        ≥25 neutrophils per low-power field on Gram stain of endotracheal aspirate or bronchoalveolar lavage specimen
      • 2.
        Worsening gas exchange (eg, desaturations, increased oxygen requirements, or increased ventilator demand)
      • 2.
        ≥2 days of stable or decreasing daily minimum PEEP followed by an increase in daily minimum PEEP of ≥2.5 cm H2O, sustained for ≥2 calendar days; or ≥2 days of stable or decreasing daily minimum Fio2 followed by an increase in daily minimum Fio2 of ≥0.15 points, sustained for ≥2 calendar days
      • 3.
        New-onset or worsening cough, or dyspnea, or tachypnea
      • 4.
        Rales or bronchial breath sounds
      Abbreviation: WBC, white blood cell.
      An accompanying editorial from the CDC-PEC suggested that the NHSN is committed to completing and implementing new quality criteria for critically ill patients in the form of VAC and IVAC (see Box 1).
      • Magill S.S.
      • Fridkin S.K.
      Improving surveillance definitions for ventilator-associated pneumonia in an era of public reporting and performance measurement.
      These streamlined quality criteria will undergo a period of review from various critical care groups and societies (Society of Critical Care Medicine, American Association of Respiratory Care, ACCP, American Thoracic Society, and American Society of Critical Care Nurses) before their expected acceptance and implementation by the National Quality Forum and the Centers for Medicare & Medicaid Services. With input from these key constituents, NHSN is prepared to make changes that will maximize reliable case identification, be responsive to new scientific findings, and simplify implementation through use of advances in health information technology, while maintaining clinical and epidemiologic credibility through partnerships with key providers and state health departments. The hope is that implementation of these new surveillance criteria will allow the quality of medical care to be more accurately assessed in the ICU setting. However, to accomplish these goals, most VACs and IVACs have to be shown to be preventable to effectively link them to health care quality.

      Bundles for quality improvement and the prevention of VAP

      More than a decade ago, an education-based program at Barnes-Jewish Hospital directed toward respiratory care practitioners and ICU nurses was developed by a multidisciplinary task force to highlight correct practices for the prevention of VAP.
      • Zack J.E.
      • Garrison T.
      • Trovillion E.
      • et al.
      Effect of an education program aimed at reducing the occurrence of ventilator-associated pneumonia.
      Each participant was required to take a preintervention test before reviewing a study module and an identical postintervention test after completion of the study module. Following implementation of the education module, the rate of VAP decreased to 5.7 per 1000 ventilator days from 12.6 per 1000 ventilator days.
      • Zack J.E.
      • Garrison T.
      • Trovillion E.
      • et al.
      Effect of an education program aimed at reducing the occurrence of ventilator-associated pneumonia.
      The cost savings secondary to the decreased rate of VAP for the 12 months following the intervention was estimated to be greater than $400,000. This educational protocol was then implemented across the 4 largest hospitals in the local health care system.
      • Babcock H.M.
      • Zack J.E.
      • Garrison T.
      • et al.
      An educational intervention to reduce ventilator-associated pneumonia in an integrated health system. A comparison of effects.
      VAP rates for all 4 hospitals combined decreased by 46%, from 8.75/1000 ventilator days in the year before the intervention to 4.74/1000 ventilator days in the 18 months following the intervention (P<.001). Statistically significant decreased rates were observed at the pediatric hospital and at 2 of the 3 adult hospitals. No significant change in VAP rates was seen at the community hospital with the lowest rate of study module completion among respiratory therapists (56%). In addition to showing the effectiveness of a bundle for VAP prevention, these studies highlight the importance of compliance with the elements of the bundle to ensure its success. This same education-based bundle package has also been successfully used in the ICUs of a hospital in Thailand.
      • Apisarnthanarak A.
      • Pinitchai U.
      • Thongphubeth K.
      • et al.
      Effectiveness of an educational program to reduce ventilator-associated pneumonia in a tertiary care center in Thailand: a 4-year study.
      Lansford and colleagues
      • Lansford T.
      • Moncure M.
      • Carlton E.
      • et al.
      Efficacy of a pneumonia prevention protocol in the reduction of ventilator-associated pneumonia in trauma patients.
      also developed a simple bundle for the prevention of VAP in patients with trauma, focusing on head of bed elevation, oral cleansing with chlorhexidine, a once-daily respiratory therapist–driven weaning attempt, and conversion of nasogastric to orogastric feeding tubes. Implementation of this bundle was associated with a significant reduction in the rate of VAP. Elements of this bundle have also been shown to be effective in other surgical/trauma units at Barnes-Jewish Hospital.
      • Sona C.S.
      • Zack J.E.
      • Schallom M.E.
      • et al.
      The impact of a simple, low-cost oral care protocol on ventilator-associated pneumonia rates in a surgical intensive care unit.
      However, compliance with infection control protocols often wanes over time and can be significantly influenced by staffing levels in the ICU.
      • Kollef M.H.
      Prevention of hospital-associated pneumonia and ventilator-associated pneumonia.
      Some institutions have used computerized flow sheets and quality rounding checklists in the ICU to improve compliance with care measures involved in the prevention of VAP, as well as other complications (eg, deep vein thrombosis, stress ulcer formation).
      • DuBose J.J.
      • Inaba K.
      • Shiflett A.
      • et al.
      Measurable outcomes of quality improvement in the trauma intensive care unit: the impact of a daily quality rounding checklist.
      • Wahl W.L.
      • Talsma A.
      • Dawson C.
      • et al.
      Use of computerized ICU documentation to capture ICU core measures.
      • Weiss C.H.
      • Moazed F.
      • McEvoy C.A.
      • et al.
      Prompting physicians to address a daily checklist and process of care and clinical outcomes: a single-site study.
      Berenholtz and colleagues
      • Berenholtz S.M.
      • Pham J.C.
      • Thompson D.A.
      • et al.
      Collaborative cohort study of an intervention to reduce ventilator-associated pneumonia in the intensive care unit.
      implemented a statewide multifaceted intervention to improve compliance with 5 evidence-based recommendations for mechanically ventilated patients and to prevent VAP. One-hundred and twelve ICUs reporting 3228 ICU months and 550,800 ventilator days showed the VAP rate to have decreased from a mean of 6.9 cases per 1000 ventilator days at baseline to a mean of 3.4 cases per 1000 ventilator days at 16 to 18 months after implementation.
      • Berenholtz S.M.
      • Pham J.C.
      • Thompson D.A.
      • et al.
      Collaborative cohort study of an intervention to reduce ventilator-associated pneumonia in the intensive care unit.
      Rello and colleagues
      • Rello J.
      • Afonso E.
      • Lisboa T.
      • et al.
      A care bundle approach for prevention of ventilator-associated pneumonia.
      conducted a VAP prevention study in 5 Spanish adult ICUs focusing on 5 evidence-based measures (avoidance of ventilator circuit changes unless clinically indicated, use of sedation control protocols, strict hand hygiene, oral care with chlorhexidine, intracuff pressure control of the endotracheal tube). Despite modest compliance with these interventions that varied between 16.4% (oral care) and 34.0% (no circuit changes), the prevention intervention achieved reductions in VAP rates, ICU length of stay, and duration of mechanical ventilation.
      Bouadma and colleagues
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      published their experience with a multimodal comprehensive intervention strategy for VAP prevention with a strong emphasis on process control. This French intervention included a multidisciplinary task force, an educational session, direct observations with performance feedback, technical improvements, and scheduled reminders. Eight evidence-based bundled interventions were systematically rolled out and used, including hand hygiene, preferably alcohol-based hand-rubbing; glove and gown use for endotracheal tube manipulation; backrest elevation of 30° to 45°; tracheal cuff pressure maintenance greater than 20 cm H2O; use of orogastric tubes; avoidance of gastric overdistension; oral hygiene with chlorhexidine; and elimination of nonessential tracheal suction. The investigators carefully monitored compliance with process indicators and VAP rates over the study period. Compliance assessment consisted of five 4-week periods (before the intervention and at 1, 6, 12, and 24 months thereafter). Compliance with procedures such as hand hygiene or wearing gloves and gowns for endotracheal tube handling were already high at study entry and remained so. Other procedures such as backrest elevation or correct tracheal cuff pressure maintenance were low and did not increase until the introduction of 2 prompts. Overall quality improvement, measured by a continuous increase in compliance with the 8 prevention measures, resulted in a 51% reduction of VAP rates.
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      Bouadma and colleagues focused on process control rather than outcome measure for sustained practice improvement and benchmarking, which is a compelling approach in the light of the unsettled dilemma of VAP definitions and the impact of case mix.
      • Pittet D.
      • Zingg W.
      Reducing ventilator-associated pneumonia: when process control allows outcome improvement and even benchmarking.
      The main advantage of such an approach is the objectivity of the process elements, which can more accurately be quantified than VAP. In addition, these same investigators compared VAP rates during a 45-month baseline period and a 30-month intervention period in a cohort of patients who received mechanical ventilation for greater than 48 hours.
      • Bouadma L.
      • Deslandes E.
      • Lolom I.
      • et al.
      Long-term impact of a multifaceted prevention program on ventilator-associated pneumonia in a medical intensive care unit.
      Baseline and intervention VAP rates were 22.6 and 13.1 total VAP episodes over total mechanical ventilation duration per 1000 ventilation-days, respectively (P<.001). These cumulative data support the use of targeted approaches for the reduction of VAP despite the limitations of the criteria used for defining VAP. They also highlight the importance of VAP as a quality indicator despite the abovementioned limitations. It will be crucial to conduct similar studies using VAC or IVAC as the quality end point to determine whether similar benefits in outcomes can be achieved.

      Selecting process elements to include in VAP prevention bundles

      The Institute for Healthcare Improvement (IHI) has put forward the simplest ventilator bundle, consisting of 4 evidence-based practices to improve the outcomes of mechanical ventilation: (1) peptic ulcer disease prophylaxis, (2) deep venous thrombosis prophylaxis, (3) elevation of head of the bed, and (4) daily sedation vacation and assessment of readiness to wean.

      Institute for healthcare improvement. Available at: http://www.ihi.org. Accessed June 3, 2011.

      Only 2 of these bundle elements (elevation of the head of the bed and sedation vacations) have been specifically evaluated as VAP prevention measures. Despite methodological flaws, a recent systematic review identified 4 peer-reviewed studies that assessed in various degrees the effect of implementing the IHI ventilator bundle on the incidence of VAP.
      • Zilberberg M.D.
      • Shorr A.F.
      • Kollef M.H.
      Implementing quality improvements in the intensive care unit: ventilator bundle as an example.
      In these studies, the incidence of VAP decreased from the range of 2.7 to 13.3 cases to 0.0 to 9.3 cases per 1000 ventilator days. In addition, 2 of the 4 studies noted a directional decline in the average ICU length of stay. The IHI bundle approach to VAP prevention, although attractively simple on the surface, may represent only an incremental first, and seemingly sensible, step to translating evidence into practice, the impact of which nevertheless remains unknown. The investigators of this review also concluded that the IHI VAP bundle and other seemingly sensible approaches to VAP prevention need to be examined for their clinical effectiveness and cost-effectiveness, particularly because new technologies or prevention strategies coming to market will require evaluation of their comparative effectiveness.
      • Kollef M.H.
      • Afessa B.
      • Anzueto A.
      • et al.
      Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial.
      • Lorente L.
      • Blot S.
      • Rello J.
      • et al.
      New issues and controversies in the prevention of ventilator-associated pneumonia.
      • Muscedere J.
      • Rewa O.
      • McKechnie K.
      • et al.
      Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis.
      Other investigations have used more targeted elements in their bundles specifically aimed at the prevention of VAP.
      • Zack J.E.
      • Garrison T.
      • Trovillion E.
      • et al.
      Effect of an education program aimed at reducing the occurrence of ventilator-associated pneumonia.
      • Babcock H.M.
      • Zack J.E.
      • Garrison T.
      • et al.
      An educational intervention to reduce ventilator-associated pneumonia in an integrated health system. A comparison of effects.
      • Apisarnthanarak A.
      • Pinitchai U.
      • Thongphubeth K.
      • et al.
      Effectiveness of an educational program to reduce ventilator-associated pneumonia in a tertiary care center in Thailand: a 4-year study.
      As previously noted, Bouadma and colleagues
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      implemented a rigorous bundle with 8 evidence-based elements directly linked to the prevention of VAP. More recently, Heimes and colleagues
      • Heimes J.
      • Braxton C.
      • Nazir N.
      • et al.
      Implementation and enforcement of ventilator-associated pneumonia prevention strategies in trauma patients.
      performed a retrospective study examining 696 consecutive ventilated patients in a level 1 trauma center to evaluate a VAP prevention bundle with 7 elements (elevate head of bed 30° or higher unless contraindicated; twice-daily oral cleansing with chlorhexidine; daily respiratory therapy–driven attempt to liberate from mechanical ventilation; nasogastric tubes replaced with orogastric tubes; sedation held and monitored daily to allow patients to follow commands; stress gastritis prophylaxis with H2 blockers or proton pump inhibitors; hand washing by health care personnel). Three time periods were assessed: pre-VAP bundle implementation, VAP bundle implementation, and a subsequent time period of VAP bundle enforcement. During the pre-VAP bundle period, 5.2 cases of VAP occurred per 1000 days of ventilator support compared with 2.4/1000 days (P = .172) and 1.2/1000 days (P = .085) in the implementation and enforcement periods, respectively. However, when all trauma patients were included, regardless of head Abbreviated Injury Score (AIS) score, the difference in the rate of VAP was statistically significant in the enforcement period, but not in the implementation period, compared with the pre-VAP bundle period (P = .014 and .062, respectively). In contrast with the study by Rello and colleagues,
      • Babcock H.M.
      • Zack J.E.
      • Garrison T.
      • et al.
      An educational intervention to reduce ventilator-associated pneumonia in an integrated health system. A comparison of effects.
      • Rello J.
      • Afonso E.
      • Lisboa T.
      • et al.
      A care bundle approach for prevention of ventilator-associated pneumonia.
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      this study supports the need for strict enforcement or compliance with VAP bundles to maximize their successful implementation.
      One of the main advantages of bundled approaches for the prevention of VAP is their simplicity and, as a result, their cost-effectiveness. VAP prevention programs have been successfully implemented in developing countries with limited resource expenditures.
      • Apisarnthanarak A.
      • Pinitchai U.
      • Thongphubeth K.
      • et al.
      Effectiveness of an educational program to reduce ventilator-associated pneumonia in a tertiary care center in Thailand: a 4-year study.
      • Rosenthal V.D.
      • Alvarez-Moreno C.
      • Villamil-Gómez W.
      • et al.
      Effectiveness of a multidimensional approach to reduce ventilator-associated pneumonia in pediatric intensive care units of 5 developing countries: International Nosocomial Infection Control Consortium findings.
      The implementation of VAP preventive measures grouped into bundles is a strategy that has consistently been shown to improve effectiveness, because the combined use of interventions is expected to achieve better outcomes than when interventions are implemented individually.
      • Al-Tawfiq J.A.
      • Abed M.S.
      Decreasing ventilator-associated pneumonia in adult intensive care units using the Institute for Healthcare Improvement bundle.
      • Morris A.C.
      • Hay A.W.
      • Swann D.G.
      • et al.
      Reducing ventilator-associated pneumonia in intensive care: impact of implementing a care bundle.
      • Ramirez P.
      • Bassi G.L.
      • Torres A.
      Measures to prevent nosocomial infections during mechanical ventilation.
      • Rewa O.
      • Muscedere J.
      Ventilator-associated pneumonia: update on etiology, prevention, and management.
      The measures that compose a bundle should be chosen based on the available scientific evidence and the expected resource availability at the local hospital level. Even when compliance with the bundle is not fully achieved, a reduction in the incidence of VAP is possible.
      • Rello J.
      • Afonso E.
      • Lisboa T.
      • et al.
      A care bundle approach for prevention of ventilator-associated pneumonia.
      • Ramirez P.
      • Bassi G.L.
      • Torres A.
      Measures to prevent nosocomial infections during mechanical ventilation.
      Similar bundles intended to prevent VACs or IVACs should be validated in prospective studies.

      Specific, measurable, achievable, relevant, time-bound approaches for quality improvement and the prevention of complications in the ICU

      Evidence-based interventions are available to reduce the occurrence of VAP, especially when these interventions are bundled together.
      • Zack J.E.
      • Garrison T.
      • Trovillion E.
      • et al.
      Effect of an education program aimed at reducing the occurrence of ventilator-associated pneumonia.
      • Babcock H.M.
      • Zack J.E.
      • Garrison T.
      • et al.
      An educational intervention to reduce ventilator-associated pneumonia in an integrated health system. A comparison of effects.
      • Apisarnthanarak A.
      • Pinitchai U.
      • Thongphubeth K.
      • et al.
      Effectiveness of an educational program to reduce ventilator-associated pneumonia in a tertiary care center in Thailand: a 4-year study.
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      To increase the likelihood of success, clinicians and administrators should follow a specific, measurable, achievable, relevant, time-bound (SMART) approach for the implementation of such quality-improvement efforts (Box 2, Fig. 1).
      • Kollef M.
      SMART approaches for reducing nosocomial infections in the ICU.
      Process-improvement initiatives in the hospital should choose specific objectives that precisely define and quantify desired outcomes, such as reducing the rate of VAP by 25% or improving compliance with specific processes (eg, compliance with identifiable VAP prevention interventions to a predetermined goal level). Such efforts should avoid unrealistic objectives, such as attempting to completely eliminate VAP or VACs, which could result in biased underreporting of VAP, or other complications, to meet the desired goal. A practical process improvement should be implemented in a way that allows both measurement of the outcome (VAP, VAC, IVAC, sVAP) and staff adherence to the elements making up the bundle for the process-improvement project. All objectives should be achievable and relevant by engaging stakeholders and empowering them to select specific tactics and steps for implementation. Nurses, respiratory therapists, and other stakeholders are in the best position to identify the preventive tactics that are achievable within their busy ICUs. Begin with simple, cost-effective tactics. Anticipate the need to add more tactics or bundle elements to achieve the desired process implementation and targeted infection/complication rates, and consider the use of certain measures designed to enforce the use of the prevention or quality-improvement program (Box 3).
      SMART approach to quality control

        Specific quality-improvement interventions

      • Use evidence-based bundle elements
      • Ensure that local resources are capable of supporting selected bundle elements
      • Do not become bound to any single bundle element if it is ineffective or impractical to implement

        Measurable outcome

      • Focus on compliance with process elements
      • Select limited but clinically relevant outcome measures (eg, VAP incidence, antibiotic use, duration of mechanical ventilation)
      • Guard against reporting biases, especially when using before-after or time-series methods

        Achievable program

      • Target 1 problem or outcome at a time
      • Do not overreach local resource capability
      • Develop a local approach to quality improvement that can be applied to subsequent problems or outcomes

        Relevant quality-improvement program

      • Target problems or outcomes that have direct clinical significance and consequences to patient care (eg, improved compliance with sedation holiday protocols or infection control protocols)
      • Update quality-improvement programs as new information, technology, or resources become available
      • Use periodic reviews of all quality-improvement programs by unbiased individuals to evaluate their success and cost-effectiveness

        Time-bound program

      • Use discrete time periods for the implementation and evaluation of each quality-improvement program
      • Develop objective parameters to determine whether quality-improvement interventions should continue, be modified, or be discontinued
      • Avoid having quality-improvement programs in place without definite periods of reevaluation
      Figure thumbnail gr1
      Fig. 1A SMART program for process improvement and quality control.
      Bundle elements for a mechanical ventilation quality program

        Mandatory elements

      • Strict hand disinfection before patient contacts
      • Use of noninvasive mask ventilation when possible
      • Orotracheal intubation preferred (when tracheal intubation is necessary)
      • Orogastric intubation preferred for gastric access
      • Appropriate use of analgesia and sedation (daily spontaneous awakening trials when stable)
      • Daily spontaneous breathing trials (in conjunction with daily spontaneous awakening trials)
      • Use of checklists or computerized order sets to optimize bundle compliance
      • Adequate ICU staffing
      • Avoidance of unplanned extubations and reintubations
      • Deep vein thrombosis prophylaxis
      • Gastrointestinal bleeding prophylaxis
      • Semierect positioning unless contraindicated because of hemodynamics (eg, shock) or therapeutics (extracorporeal membrane oxygenation)
      • Avoid ventilator circuit changes unless clinically indicated
      • Early use of physical therapy and mobilization

        Other elements for bundle consideration

      • Avoidance of patient transports unless clearly clinically indicated
      • Use of closed endotracheal suctioning
      • Subglottic secretion drainage
      • Adequate endotracheal tube cuff pressure
      • Oral chlorhexidine
      • Appropriate nutritional support (to include optimal delivery route)
      • Glucose control
      • Pressure sore avoidance strategy in place

        Enforcement measures

      • Computerized order sets for bundle elements
      • Use of rounding checklists
      • Compliance assessments using random surveillance or observation periods
      • Distribution of report cards and infection rates
      • Involvement of hospital leadership in the review of prevention program outcomes
      • Scheduled in-services, educational briefings, and town hall sessions to review procedures, outcomes, and barriers to successful bundle implementation
      All process-improvement efforts should be periodically reviewed to assess compliance with their elements and sustained ability to achieve targeted goals, and to introduce advances in technology or behavioral science techniques. Bouadma and colleagues
      • Bouadma L.
      • Mourvillier B.
      • Deiler V.
      • et al.
      A multifaceted program to prevent ventilator-associated pneumonia: impact on compliance with preventive measures.
      • Bouadma L.
      • Deslandes E.
      • Lolom I.
      • et al.
      Long-term impact of a multifaceted prevention program on ventilator-associated pneumonia in a medical intensive care unit.
      showed the ability of such rigorous methods to produce sustained VAP rate decreases in the long term. However, these investigators also showed that VAP rates remained substantial at their institution despite high compliance with preventive measures, suggesting that elimination of VAP, or other VACs, may be an unrealistic goal. Therefore, the focus of such quality-improvement efforts should be process driven to maximize the benefits of available hospital resources for the desired goal (eg, reduced occurrence of VAP or VACs).

      Summary

      Given the rising costs of health care and limited government budgets, process improvement, safety, and quality should be hardwired into the culture of hospitals, and this is becoming increasingly evident as more institutions are adopting Toyota-inspired quality management strategies to improve quality as well as to reduce hospital costs.
      • Culig M.H.
      • Kunkle R.F.
      • Frndak D.C.
      • et al.
      Improving patient care in cardiac surgery using Toyota production system based methodology.
      Moreover, until more objective surveillance end points, such as sVAP, VAC, or IVAC, are developed and validated, it will be difficult to compare quality-improvement efforts across sites or to know what levels of improved medical care (eg, zero VAP or VAC rates) can be achieved.
      Health care providers and hospital administration should strive to provide the highest level of medical care possible. Nowhere is this more important than high-intensity resource areas such as the ICU. Intensivists, critical care nurses, and other support personnel will continue to be challenged to keep pace with rapidly advancing changes in medical care and technology. The use of a simplified quality indicator, such as VAC or IVAC, holds the promise of allowing quality to be surveyed over time and across centers. However, it is imperative that such markers of quality first be validated as representing preventable events that can be intervened on.

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