The Effectiveness of the Modified Bundle in the Prevention of Ventilator-associated Pneumonia in Adult Patients in the Intensive Care Unit.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- VAP - Ventilator Associated Pneumonia
- Sponsor
- Andrzej Frycz Modrzewski Krakow University
- Enrollment
- 386
- Locations
- 1
- Primary Endpoint
- Early VAP
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
JAROSLAW PAWLIK
MD, Specialist of anaesthesiology and intensive care, An assistant of The Faculty of Medicine and Health Sciences
Andrzej Frycz Modrzewski Krakow University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Early VAP
Time Frame: 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
Time Frame: day: 6 - the last day in ICU
total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms
Secondary Outcomes
- Mortality(day: 1 - 28)
- MV(day: 1 - the last day in the ICU, but at least 2 days)
- LOS(day: 1 - the last day in the ICU, but at least 2 days)
- nonMV(day: 1 - the last day in the ICU,)
- MDR(day: 1 - the last day in the ICU,)