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Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.

Sponsor
University of Southern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05102630
Collaborator
Odense University Hospital (Other), Aalborg University Hospital (Other), Bispebjerg Hospital (Other), Herlev and Gentofte Hospital (Other), Hvidovre University Hospital (Other), Rigshospitalet, Denmark (Other), Aarhus University Hospital (Other), Region Zealand (Other)
1,193
Enrollment
2
Locations
10
Anticipated Duration (Months)
596.5
Patients Per Site
59.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19.

This study is designed to be a retrospective study focusing on all mechanical ventilated ICU patients with COVID-19 included in the national Danish COVID ICU database between 10.03.2020

  • 02.04.2021 i.e. a total of 1,193 patients. The investigators will register the use of the core interventions around mechanical ventilation and its potential adverse event, including barotrauma and prolonged ventilation.

This study will provide important data on the ventilation strategies used and its potential adverse events in unselected ICU patients with COVID-19 and thereby inform clinicians, patients, policy-makers, and future research in this area.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1193 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    The Use of Mechanical Ventilation Strategies and Its Potential Adverse Events Among ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI. [Until 90 days]

      Low tidal volume ventilation (Vt 4-8 mL/kg of predicted body weight)

    Secondary Outcome Measures

    1. Pneumothorax [Until 90 days]

      Pneumothorax noted in the medical record

    2. Ventilator days [Until 90 days]

      Number of days where the patients where the patient is ventilator depended

    3. Number of patients with prolonged ventilation [Until 90 days]

      Patients with more than 30 ventilator days

    4. paO2/FiO2 ratio on days of ventilation [Until 90 days]

      Ratio between measured arterial oxygen pressure and the fraction of inhaled oxygen

    5. The use of APRV [Until 90 days]

      The use of Airway pressure release as primary ventilator setting

    6. Prone position [Until 90 days]

      The use of prone position within the first 3 days and the use of prone position after day 3

    7. Time to spontaneous ventilation [Until 90 days]

      Time measured in days until the patients no longer needs controlled ventilation

    8. Tracheostomy [Until 90 days]

      Day after first intubation, Percutaneous dilatational tracheostomy (y/n), Surgical tracheostomy (y/n)

    9. Adjuvant drugs [Until 90 days]

      Adjuvant drugs at any time during mechanical ventilation

    10. Mortality [Until 90 days]

      Mortality at day 90

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    All mechanical ventilated patients registered in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e.

    1. Admitted to an ICU in Denmark

    2. Laboratory-confirmed SARS-CoV-2 infection

    3. Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at any time during the ICU stay

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital Aalborg Denmark 9000
    2 Department of Anesthesiology and Intensive Care, Kolding Hospital Kolding Denmark 6000

    Sponsors and Collaborators

    • University of Southern Denmark
    • Odense University Hospital
    • Aalborg University Hospital
    • Bispebjerg Hospital
    • Herlev and Gentofte Hospital
    • Hvidovre University Hospital
    • Rigshospitalet, Denmark
    • Aarhus University Hospital
    • Region Zealand

    Investigators

    • Principal Investigator: Anne C Brøchner, MD, PhD, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Craveiro Brøchner, Ph D, associate professor, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT05102630
    Other Study ID Numbers:
    • 2020-C 19-29-10-21
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anne Craveiro Brøchner, Ph D, associate professor, University of Southern Denmark
    ARDS
    Mechanical Ventilation
    COVID-19
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 11, 2021