Clinical trial NCT05102630: Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS Due to COVID-19
Keywords: ARDS
Mechanical Ventilation
COVID-19
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Aalborg University Hospital
name: Bispebjerg Hospital
name: Herlev and Gentofte Hospital
name: Hvidovre University Hospital
name: Rigshospitalet, Denmark
name: Aarhus University Hospital
name: Region Zealand
First posted: 2021-11-01
Enrollment: 1193
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All mechanical ventilated patients registered in the national Danish COVID ICU database

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.


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.

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

Primary outcomes:
measure: Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI.
timeFrame: Until 90 days
Secondary outcomes:
measure: Pneumothorax
timeFrame: Until 90 days
measure: Ventilator days
timeFrame: Until 90 days
measure: Number of patients with prolonged ventilation
timeFrame: Until 90 days
measure: paO2/FiO2 ratio on days of ventilation
timeFrame: Until 90 days
measure: The use of APRV
timeFrame: Until 90 days
measure: Prone position
timeFrame: Until 90 days
measure: Time to spontaneous ventilation
timeFrame: Until 90 days
measure: Tracheostomy
timeFrame: Until 90 days
measure: Adjuvant drugs
timeFrame: Until 90 days
measure: Mortality
timeFrame: Until 90 days
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital
city: Kolding
country: Denmark
facility: Department of Anesthesiology and Intensive Care, Kolding Hospital
Study officials:
affiliation: University of Southern Denmark
name: Anne C Brøchner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: