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

NCT05102630 | Unknown

• 1 other identifier: 2020-C 19-29-10-21
• Study Type: observational
• Target: 1,193
• Locations: 1 country
• Sites: 2

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.

Conditions

ARDS Due to COVID-19

Keywords

ARDS; Mechanical Ventilation; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pneumothorax

  Until 90 days

• Ventilator days

  Until 90 days

• Number of patients with prolonged ventilation

  Until 90 days

• paO2/FiO2 ratio on days of ventilation

  Until 90 days

• The use of APRV

  Until 90 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (2)

Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Department of Anesthesiology and Intensive Care, Kolding Hospital

Kolding, 6000, Denmark

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anne C Brøchner, MD, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne C Brøchner, MD, Ph D

CONTACT

+4529464468; anne.craveiro.broechner@rsyd.dk

Nikolai arnold-larsen, MD

CONTACT

nikolai.arnold-larsen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D, associate professor

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 1, 2021
• Study Start: June 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)