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PRoVAcT-COVID: PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.

Sponsor
Prof. Dr. Marcus J. Schultz (Other)
Overall Status
Completed
CT.gov ID
NCT05954351
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
2,465
Enrollment
1
Location
14
Actual Duration (Months)
176.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2465 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?
    Actual Study Start Date :
    May 1, 2022
    Actual Primary Completion Date :
    Jul 1, 2023
    Actual Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. ICU mortality [90 days from inclusion]

    Secondary Outcome Measures

    1. Duration of ventilation [90 days from inclusion]

    2. 28-day ventilator free days [90 days from inclusion]

    3. 28-day, 90-day mortality [90 days from inclusion]

    4. ICU and hospital length of stay [90 days from inclusion]

    Other Outcome Measures

    1. Acute kidney injury [90 days from inclusion]

    2. duration of ventilation in survivors [90 days from inclusion]

    3. use of muscle paralysis [90 days from inclusion]

    4. vasopressor or inotrope administration [90 days from inclusion]

    5. occurrence of tracheostomy [90 days from inclusion]

    6. pneumothorax and thromboembolic complications [90 days from inclusion]

    7. use of immunomodulating drugs [90 days from inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2

    • admitted to one of the ICUs of the participating hospitals

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Medical Center Amsterdam Noord-Holland Netherlands 1105 AZ

    Sponsors and Collaborators

    • Prof. Dr. Marcus J. Schultz
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Marcus J. Schultz, Prof. Dr. Marcus J. Schultz, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
    ClinicalTrials.gov Identifier:
    NCT05954351
    Other Study ID Numbers:
    • PRoVAcT-COVID
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Jul 20, 2023