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The Effectiveness of the Modified Bundle in the Prevention of VAP.

A

Andrzej Frycz Modrzewski Krakow University

Status

Completed

Conditions

VAP - Ventilator Associated Pneumonia

Treatments

Procedure: Routine prevention of VAP
Procedure: Modified prevention of VAP

Study type

Observational

Funder types

Other

Identifiers

NCT04038814
AFMKrakowU

Details and patient eligibility

About

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.

Enrollment

386 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

386 participants in 2 patient groups

VAP1 - historical group
Description:
Routine prevention of VAP
Treatment:
Procedure: Routine prevention of VAP
VAP2 - study group
Description:
Modified prevention of VAP
Treatment:
Procedure: Modified prevention of VAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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