The Effectiveness of the Modified Bundle in the Prevention of VAP.
VAP
1 other identifier
observational
386
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
July 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedJuly 31, 2019
July 1, 2019
1.1 years
July 27, 2019
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Early VAP
Total VAP cases in the ICU ( CEPPIS /Chest Echocardiography and Procalcitonin Pulmonary Infection Score/ criteria ) with early beginning of the pneumonia symptoms.
day: 2 - 5 of mechanical ventilation
Late VAP
total VAP cases in the ICU ( CEPPIS criteria ) with late beginning of the pneumonia symptoms
day: 6 - the last day in ICU
Secondary Outcomes (5)
LOS
day: 1 - the last day in the ICU, but at least 2 days
MV
day: 1 - the last day in the ICU, but at least 2 days
nonMV
day: 1 - the last day in the ICU,
Mortality
day: 1 - 28
MDR
day: 1 - the last day in the ICU,
Study Arms (2)
VAP1 - historical group
Routine prevention of VAP
VAP2 - study group
Modified prevention of VAP
Interventions
Enhanced hand hygiene protocol, tube cuff pressure monitoring ( set on 25-30 mm Hg) every 12 hours and every time when we suspected under or over distention, fast withdrawal of sedation, moderate supportive mechanical ventilation ( tidal volume (VT) 5-8 ml/kg ideal body weight (IBW), positive end expiratory pressure (PEEP) 3-5 cmH2O, Plateau pressure (Ppl) \< 25 cm H2O, normocapnia ), Proton Pump Inhibitors (PPIs) reduction, Selective oral decontamination (SOD) every 8 hours - 0,2% chlorhexidine digluconate mouthwash, Closed Tracheal Suction System (CTSS) - changed every 7 day, 30-45% lifting of the thorax
3 modifications of the routine bundle in the prevention of VAP: * Endotracheal tube ( Shiley Evac Endotracheal tube with TaperGuard Cuff) and tracheostomy tubes (Tracheostomy Tube Cuffed Seal Guard) instead of regular tubes, * Automatic, continuous tube cuff pressure monitoring ( Covidien Shiley M Pressure Control Automatic Cuff Controller ( 25-30 mmHg), * Automatic continuous subglottic secretion drainage
Eligibility Criteria
The study group were male and female patients ( neurosurgical, cardiological, general surgical and non cardiological internal medicine type) in adult ICU. Each enrolled patient was mechanically ventilated for a period longer than 48 hours.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anaesthesiology and Intensive Care Unit St. Raphael Hospital
Krakow, Małopolska, 30-693, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JAROSLAW PAWLIK, MD
Andrzej Frycz Modrzewski Krakow University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Specialist of anaesthesiology and intensive care, An assistant of The Faculty of Medicine and Health Sciences
Study Record Dates
First Submitted
July 27, 2019
First Posted
July 31, 2019
Study Start
June 1, 2018
Primary Completion
July 1, 2019
Study Completion
July 15, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07