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

ARDS Due to COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102630
• Other study ID #: 2020-C 19-29-10-21
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: April 2022

Study information

• Verified date: November 2021
• Source: University of Southern Denmark
• Contact: Anne C Brøchner, MD, Ph D
• Phone: +4529464468
• Email: anne.craveiro.broechner[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1193
• Est. completion date: April 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS Due to COVID-19
• COVID-19

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital	Aalborg
Denmark	Department of Anesthesiology and Intensive Care, Kolding Hospital	Kolding

Sponsors (9)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.	Low tidal volume ventilation (Vt 4-8 mL/kg of predicted body weight)	Until 90 days
Secondary	Pneumothorax	Pneumothorax noted in the medical record	Until 90 days
Secondary	Ventilator days	Number of days where the patients where the patient is ventilator depended	Until 90 days
Secondary	Number of patients with prolonged ventilation	Patients with more than 30 ventilator days	Until 90 days
Secondary	paO2/FiO2 ratio on days of ventilation	Ratio between measured arterial oxygen pressure and the fraction of inhaled oxygen	Until 90 days
Secondary	The use of APRV	The use of Airway pressure release as primary ventilator setting	Until 90 days
Secondary	Prone position	The use of prone position within the first 3 days and the use of prone position after day 3	Until 90 days
Secondary	Time to spontaneous ventilation	Time measured in days until the patients no longer needs controlled ventilation	Until 90 days
Secondary	Tracheostomy	Day after first intubation, Percutaneous dilatational tracheostomy (y/n), Surgical tracheostomy (y/n)	Until 90 days
Secondary	Adjuvant drugs	Adjuvant drugs at any time during mechanical ventilation	Until 90 days
Secondary	Mortality	Mortality at day 90	Until 90 days