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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54CK000172-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Washington University School of Medicine | OTHER |
| Rush University Medical Center | OTHER |
| University of Pennsylvania |
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Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation associated with significant morbidity, including prolongation of mechanical ventilation and increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily sedative interruptions and daily spontaneous breathing trials can improve sedative management, decrease ventilator time, improve outcomes for mechanically ventilated patients,and possibly decrease VAP.Combining daily sedative interruption with daily spontaneous breathing trials confers additive improvement in ventilator days, intensive care days, and possibly mortality compared to daily spontaneous breathing trials alone.
The primary aim of this study is to determine the impact of an opt-out protocol for paired daily sedative interruptions and spontaneous breathing trials on VAP rates using a new streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's proposed new surveillance definitions for ventilator-associated events to this quality improvement initiative. The study will be nested within the Epicenters Streamlined versus Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be participating in this intervention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt Out Protocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily SAT & SBT | Procedure | Nurse and/or respiratory therapist led daily awakenings from sedation (spontaneous awakening trial, or SAT) and daily performance of a spontaneous breathing trial (SBT) among mechanically ventilated, critically ill patients in participating ICUs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAC rate. | A new definition for VAP is the primary focus of this study. This new definition (referred to as "streamlined VAP" or "sVAP") is under consideration by the CDC as a potential replacement for the current NHSN VAP definition and, as such, will be closely evaluated to determine if it can reflect meaningful changes in patient care. Thus, we will assess the change in monthly sVAP rates from study start to study end using an interrupted time series analysis. Note that CDC released new surveillance definitions for ventilator-associated events in late 2012. Given that CDC definitions are the defacto surveillance standard, we switched the primary study outcome from sVAP to ventilator-associated conditions ("VAC"). All data elements required to assess for VAC were included in this study from the outset hence we did not have to collect any additional historical data in order to apply CDC's VAC definition. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-specific outcomes |
| 12-months |
| Hospital-specific outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Klompas, MD, MPH | Harvard Pilgrim Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Prevention Epicenter | Chicago | Illinois | United States | |||
| North Shore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25369558 | Derived | Klompas M, Anderson D, Trick W, Babcock H, Kerlin MP, Li L, Sinkowitz-Cochran R, Ely EW, Jernigan J, Magill S, Lyles R, O'Neil C, Kitch BT, Arrington E, Balas MC, Kleinman K, Bruce C, Lankiewicz J, Murphy MV, E Cox C, Lautenbach E, Sexton D, Fraser V, Weinstein RA, Platt R; CDC Prevention Epicenters. The preventability of ventilator-associated events. The CDC Prevention Epicenters Wake Up and Breathe Collaborative. Am J Respir Crit Care Med. 2015 Feb 1;191(3):292-301. doi: 10.1164/rccm.201407-1394OC. |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D015610 | Serum Bactericidal Test |
| ID | Term |
|---|---|
| D008826 | Microbial Sensitivity Tests |
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER |
| Duke University | OTHER |
| North Shore Medical Center | OTHER |
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|
| 12-months |
| Patient-specific outcomes |
The above results will also be assessed separately for patients who received opt-out protocol care versus those who did not. | 12-months |
| Salem |
| Massachusetts |
| United States |
| Washington University Prevention Epicenter | St Louis | Missouri | United States |
| Duke University Prevention Epicenter | Durham | North Carolina | United States |
| University of Pennsylvania Prevention Epicenter | Philadelphia | Pennsylvania | United States |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004353 | Drug Evaluation, Preclinical |
| D005069 | Evaluation Studies as Topic |