N/A
N=4,892
Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial
VAP - Ventilator Associated Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT05176353 ↗Enrolled (actual)
4,892
Serious AEs
6.4%
Results posted
Dec 2024
Primary outcome: Primary: Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days — 72; 73 Deaths per 1000 patient-days — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VAP diagnostic stewardship bundle (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Deaths in the Pre vs Post-intervention Time Periods Among Study Participants Per 1000 Mechanically Ventilated Patient Days |
72; 73 | 0.86 |
| PRIMARY Change in Ventilator-associated Events (V-A Events) (Using Centers for Disease Control/National Healthcare Safety Network Definitions) Per 1000 Patient Days |
15; 10 | 0.05 |
| PRIMARY Median Duration of Mechanical Ventilation Per Patient |
3; 3 | 0.59 |
| SECONDARY Number of Positive Respiratory Cultures (RCs) Per 1,000 Mechanically-ventilated Patient Days (MVPDs) |
127; 102 | <0.01 sig |
| SECONDARY Total ICU Antibiotic Utilization Rates |
1361; 1335 | 0.20 |
| SECONDARY Broad-spectrum ICU Antibiotic Utilization Rates |
1199; 1149 | 0.03 sig |
| SECONDARY Number of Respiratory Cultures Ordered Per 1000 Mechanically-ventilated Patient Days |
334; 268 | <0.01 sig |
| SECONDARY Percentage of Respiratory Cultures Obtained by Bronchoalveolar Lavage (BAL) |
53.1; 56.9 | .05 |
| SECONDARY Percentage of Respiratory Cultures From BAL Samples With Alveolar Neutrophils <50% Following Study Intervention. |
4.3 | — |
Summary
This is a prospective pilot/feasibility trial of a bundled diagnostic stewardship intervention at the level of the microbiologic testing pathway in ventilator-associated pneumonia (VAP). The study utilized a pre/post design and was initially registered as a single-arm trial because the study intervention could only be applied prospectively to a single group (all patients hospitalized in study ICUs requiring ventilation during the trial intervention period). The study objectives are to safely and effectively reduce antibiotic overuse and its attendant hazards (adverse drug events, Clostridioides difficile diarrhea and generation of multidrug-resistant organisms) among mechanically-ventilated patients. Participating ICUs will have the following three modifications made in their respiratory culture workflows for mechanically-ventilated patients: 1) providers will be required to select a valid indication for respiratory culture performance (worsening ventilator requirements, purulent sputum production, and/or new radiographic infiltrate on chest imaging); 2) respiratory cultures will be preferentially obtained via bronchoscopic or nonbronchoscopic BAL (by respiratory therapists) rather than via endotracheal aspiration; and 3) BAL samples will be sent for cell count and differentials, and respiratory culture results will not be released for samples with <50% neutrophils. The study will carefully monitor adherence to study interventions, ICU-specific antibiotic utilization rates, and important safety metrics including rates of mortality, ventilator-dependence and ventilator-associated events.
The trial hypotheses are:
* Implementation of a VAP diagnostic stewardship bundle will be successfully implemented without significant increases in mortality or ventilator-associated events.
* Implementation of a VAP diagnostic stewardship bundle will be associated with a reduction in ICU-specific antibiotic utilization rates
Eligibility Criteria
Inclusion Criteria Patients included:
- All patients hospitalized within the Michigan Medicine Cardiac Care Unit (CCU, 7D) and the Michigan Medicine Critical Care Medicine Unit (CCMU, 6D)
Exclusion Criteria Patients included:
- For the study intervention requiring performance of bronchoalveolar lavage rather than endotracheal aspirate for respiratory culture collection, the following are exclusion criteria for performance of bronchoalveolar lavage:
- international normalized ratio (INR)>2,
- platelet count <50,
- gross blood in endotracheal secretions,
- ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2), ratio (P/F ratio)<80,
- major lung surgery within prior 30 days.
Inclusion Criteria healthcare providers included:
- healthcare providers working in units (CCU and CCMU) as part of routine clinical care.
Exclusion Criteria healthcare providers included:
- healthcare providers that are not as part of routine care in CCU and CCMU
Data sourced from ClinicalTrials.gov (NCT05176353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.