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NCT04038814: VAP

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

Completed Last updated 31 July 2019
What this trial tests

trial testing Routine prevention of VAP in VAP - Ventilator Associated Pneumonia in 386 participants. Completed in 15 July 2019.

Timeline
1 June 2018
Primary endpoint
1 July 2019
15 July 2019

Quick facts

Lead sponsorAndrzej Frycz Modrzewski Krakow University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment386
Start date1 June 2018
Primary completion1 July 2019
Estimated completion15 July 2019
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Andrzej Frycz Modrzewski Krakow University

Who can join

18 and older, any sex, with VAP - Ventilator Associated Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Risk Factors and Protective Factors against Ventilator-Associated Pneumonia-A Single-Center Mixed Prospective and Retrospective Cohort Study.
    Pawlik J, Tomaszek L, Mazurek H, Mędrzycka-Dąbrowska W. · · 2022 · cited 14× · PMID 35455713 · DOI 10.3390/jpm12040597
  2. Automatic Continuous Control of Cuff Pressure and Subglottic Secretion Suction Used Together to Prevent Pneumonia in Ventilated Patients-A Retrospective and Prospective Cohort Study.
    Tomaszek L, Pawlik J, Mazurek H, Mędrzycka-Dąbrowska W. · · 2021 · cited 3× · PMID 34768471 · DOI 10.3390/jcm10214952

Verify or expand the search:

Other recruiting trials for VAP - Ventilator Associated Pneumonia

Currently open trials in the same condition.

Other Andrzej Frycz Modrzewski Krakow University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing