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

• Conditions: ARDS Due to COVID-19

• Registration Number: NCT05102630
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Status Verified: 2021-11
• Study First Posted: 2021-11-01
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11
• Primary Completion: 2022-02
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Tracheostomy	Until 90 days	Day after first intubation, Percutaneous dilatational tracheostomy (y/n), Surgical tracheostomy (y/n)
Number of patients with prolonged ventilation	Until 90 days	Patients with more than 30 ventilator days
Prone position	Until 90 days	The use of prone position within the first 3 days and the use of prone position after day 3
Adjuvant drugs	Until 90 days	Adjuvant drugs at any time during mechanical ventilation
Ventilator days	Until 90 days	Number of days where the patients where the patient is ventilator depended
The use of APRV	Until 90 days	The use of Airway pressure release as primary ventilator setting
Pneumothorax	Until 90 days	Pneumothorax noted in the medical record
Mortality	Until 90 days	Mortality at day 90
Time to spontaneous ventilation	Until 90 days	Time measured in days until the patients no longer needs controlled ventilation
paO2/FiO2 ratio on days of ventilation	Until 90 days	Ratio between measured arterial oxygen pressure and the fraction of inhaled oxygen

Trial Locations

Locations (2)

Department of Anesthesiology and Intensive Care, Kolding Hospital; 🇩🇰 Kolding, Denmark

Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark