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Clinical Trials/NCT04668196
NCT04668196
Completed
Not Applicable

Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)

Hospital Universitari Vall d'Hebron Research Institute10 sites in 1 country367 target enrollmentMay 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
367
Locations
10
Primary Endpoint
Treatment failure
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.

Detailed Description

Multicenter, retrospective, longitudinal study in consecutive adult COVID-19 patients with acute respiratory failure, requiring noninvasive respiratory support (NIRS) outside the intensive care unit (ICU) in 10 hospitals in Catalonia (Spain). Demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section). During the hospitalization, patients were treated according to the standard procedures of the participating centers. This study is observational and no randomization have been performed. Patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from NIRS initiation.

Registry
clinicaltrials.gov
Start Date
May 22, 2020
End Date
January 25, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • COVID-19 pneumonia confirmed with polymerase chain reaction (PCR).
  • Acute respiratory failure.
  • Treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP or noninvasive ventilation), initiated outside the intensive care unit.
  • Age \> 18 years

Exclusion Criteria

  • Acute respiratory failure not related to COVID-19
  • Hypercapnic acute respiratory failure
  • Early intolerance to treatment
  • Nosocomial infection
  • Pregnant woman

Outcomes

Primary Outcomes

Treatment failure

Time Frame: 28 days within noninvasive respiratory support initiation

Death or endotracheal intubation

Secondary Outcomes

  • Duration of hospital stay(Until 28 days from noninvasive respiratory support initiation)
  • 28-day mortality(28 days within noninvasive respiratory support initiation)
  • Hospital mortality(Until 28 days from noninvasive respiratory support initiation)
  • Endotracheal intubation(28 days within noninvasive respiratory support initiation)

Study Sites (10)

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