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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05102630

Enrollment

1193

Registered

2021-11-01

Start date

2021-06-01

Completion date

2022-04-30

Last updated

2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS Due to COVID-19

Keywords

ARDS, Mechanical Ventilation, COVID-19

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Contacts

Primary ContactAnne C Brøchner, MD, Ph D

anne.craveiro.broechner@rsyd.dk+4529464468

Backup ContactNikolai arnold-larsen, MD

nikolai.arnold-larsen@rsyd.dk

Outcome results