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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS Due to COVID-19

• Study Type: Observational
• Enrollment (Anticipated): 1193

Contacts and Locations

• Study Contact: Name: Anne C Brøchner, MD, Ph D; Phone Number: +4529464468; Email: anne.craveiro.broechner@rsyd.dk
• Study Contact Backup: Name: Nikolai arnold-larsen, MD; Email: nikolai.arnold-larsen@rsyd.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital
    • Contact: Frederik Nielsen, MD; Phone Number: (+45) 97 66 19 24; Email: frederik.nielsen@rn.dk
  • Kolding, Denmark, 6000
    • Recruiting
    • Department of Anesthesiology and Intensive Care, Kolding Hospital
    • Contact: Anne C Brøchner, MD, Ph D; Phone Number: 29464468; Email: anne.craveiro.broechner@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All mechanical ventilated patients registered in the national Danish COVID ICU database

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Hvidovre University Hospital; Bispebjerg Hospital; Aalborg University Hospital; Herlev and Gentofte Hospital; Region Zealand
• Investigators: Principal Investigator: Anne C Brøchner, MD, PhD, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Mechanical Ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-C 19-29-10-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No