Skip to main content
Clinical Trials/NCT05102630
NCT05102630
Unknown
Not Applicable

The Use of Mechanical Ventilation Strategies and Its Potential Adverse Events Among ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.

University of Southern Denmark2 sites in 1 country1,193 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS Due to COVID-19
Sponsor
University of Southern Denmark
Enrollment
1193
Locations
2
Primary Endpoint
Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
April 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Craveiro Brøchner

Ph D, associate professor

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • All mechanical ventilated patients registered in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e.
  • Admitted to an ICU in Denmark
  • Laboratory-confirmed SARS-CoV-2 infection
  • Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at any time during the ICU stay

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.

Time Frame: Until 90 days

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

Secondary Outcomes

  • Number of patients with prolonged ventilation(Until 90 days)
  • Prone position(Until 90 days)
  • Adjuvant drugs(Until 90 days)
  • The use of APRV(Until 90 days)
  • Pneumothorax(Until 90 days)
  • Ventilator days(Until 90 days)
  • Mortality(Until 90 days)
  • Time to spontaneous ventilation(Until 90 days)
  • paO2/FiO2 ratio on days of ventilation(Until 90 days)
  • Tracheostomy(Until 90 days)

Study Sites (2)

Loading locations...

Similar Trials