The Effectiveness of the Modified Bundle in the Prevention of VAP.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Interventions
- Procedure: Routine prevention of VAPProcedure: Modified prevention of VAP
- Registration Number
- NCT04038814
- Lead Sponsor
- Andrzej Frycz Modrzewski Krakow University
- Brief Summary
Ventilator-associated pneumonia (VAP) is an important cause of prolonged intensive care unit and hospital length of stay, healthcare costs and mortality in mechanically ventilated patients. There are an international guidelines for VAP diagnosis, treatment and prevention (Infectious Diseases Society of America(IDSA)/American Thoracic Society (ATS) 2016 and European Respiratory Society (ERS) / European Society of Intensive Care Medicine (ESICM) / European Society of Clinical Microbiology and Infectiuos Diseases (ESCMID) / Asociacion Latinoamericana del Torax (ALAT) 2017) routinely used in most ICUs. The investigator planed on comparing two strategies for prevention of VAP in mechanically ventilated patients: the routine VAP bundle ( historical group - VAP1) and the modified VAP bundle ( study group - VAP2) by using 3 modifications ( Shiley Evac Endotracheal tube with TaperGuard Cuff, Automatic continuous subglottic secretion drainage (SSD) and continuous tube cuff pressure monitoring).
The aim of the study is an assessment of the effectiveness of the modified prevention of VAP in reduction of: early and late VAP cases, mechanical ventilation days (MV), length of stay (LOS) in the ICU, 28 day mortality and multi drug resistent pathogens (MDR) cases in adult ICU patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
VAP2 - study group
- mechanically ventilated patients with an artificial airways (endotracheal tube, tracheostomy tube)
- age over 18 years
- modified bundle in the prevention of VAP
VAP1 - historical group
- mechanically ventilated patients with an artificial airways (endotracheal tube, tracheostomy tube)
- patients hospitalised in the ICU for last 12 months before modified bundle in the prevention of VAP has been started (from 01.05.2017 to 30.04.2018)
- age over 18 years
- routine bundle in the prevention of VAP
- lack of an informed consent in awake patients in the ICU
- age under 18 years
- patients with no mechanical ventilation in the ICU
- patients with probability of mechanical ventilation days and LOS in the ICU less than 48 hours
- patients intubated and mechanically ventilated without the bundle in the prevention of VAP for a period of time longer than 12 hours before the admission to the ICU
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VAP1 - historical group Routine prevention of VAP Routine prevention of VAP VAP2 - study group Modified prevention of VAP Modified prevention of VAP
- Primary Outcome Measures
Name Time Method Early VAP day: 2 - 5 of mechanical ventilation Total VAP cases in the ICU ( CEPPIS /Chest Echocardiography and Procalcitonin Pulmonary Infection Score/ criteria ) with early beginning of the pneumonia symptoms.
Late VAP day: 6 - the last day in ICU total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms
- Secondary Outcome Measures
Name Time Method Mortality day: 1 - 28 Mortality of adult mechanically ventilated patients in the ICU
MV day: 1 - the last day in the ICU, but at least 2 days Duration of mechanical ventilation (days) in the ICU
LOS day: 1 - the last day in the ICU, but at least 2 days lenght of stay in the ICU (days)
nonMV day: 1 - the last day in the ICU, Total non mechanical ventilation days in the ICU
MDR day: 1 - the last day in the ICU, Number of cases with multi drug resistant (MDR) pathogens detected in specimens of mucus taken from the lower airways in mechanically ventilated patients in the ICU.
Trial Locations
- Locations (1)
Anaesthesiology and Intensive Care Unit St. Raphael Hospital
🇵🇱Kraków, Małopolska, Poland