Clinical trial NCT04038814: The Effectiveness of the Modified Bundle in the Prevention of VAP.
Official title: The Effectiveness of the Modified Bundle in the Prevention of Ventilator-associated Pneumonia in Adult Patients in the Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: VAP - Ventilator Associated Pneumonia
Keywords: VAP
Evac Endotracheal Tube with TaperGuard Cuff
MDR - multi drug resistant pathogens
SSD - subglottic secretion drainage,
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Early VAP
timeFrame: day: 2 - 5 of mechanical ventilation
measure: Late VAP
timeFrame: day: 6 - the last day in ICU
Secondary outcomes:
measure: LOS
timeFrame: day: 1 - the last day in the ICU, but at least 2 days
measure: MV
timeFrame: day: 1 - the last day in the ICU, but at least 2 days
measure: nonMV
timeFrame: day: 1 - the last day in the ICU,
measure: Mortality
timeFrame: day: 1 - 28
measure: MDR
timeFrame: day: 1 - the last day in the ICU,
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Anaesthesiology and Intensive Care Unit St. Raphael Hospital
state: Małopolska
Study officials:
affiliation: Andrzej Frycz Modrzewski Krakow University
name: JAROSLAW PAWLIK, MD
role: PRINCIPAL_INVESTIGATOR
References: