Noninvasive Respiratory Support in COVID-19 (CATCOVID-AIR)

Completed

• Conditions: Covid19; Corona Virus Infection; Acute Respiratory Failure
• Interventions: Device: High-flow nasal cannula treatment; Device: Continuous positive airway pressure (CPAP) treatment; Device: Noninvasive ventilation treatment

• Registration Number: NCT04668196
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2020-05-22
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-16
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-flow nasal cannula treatment	High-flow nasal cannula treatment	-
Continuous positive airway pressure (CPAP) treatment	Continuous positive airway pressure (CPAP) treatment	-
Noninvasive ventilation treatment	Noninvasive ventilation treatment	-

Primary Outcome Measures

Name	Time	Method
Treatment failure	28 days within noninvasive respiratory support initiation	Death or endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Until 28 days from noninvasive respiratory support initiation	Time between admission and discharge from hospital or death in hospital
28-day mortality	28 days within noninvasive respiratory support initiation
Hospital mortality	Until 28 days from noninvasive respiratory support initiation	Any death during hospital stay
Endotracheal intubation	28 days within noninvasive respiratory support initiation

Trial Locations

Locations (10)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Fundació Althaia; 🇪🇸 Manresa, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari Mútua Terrassa; 🇪🇸 Terrassa, Bardelona, Spain

Hospital del Mar, Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Dr.Josep Trueta; 🇪🇸 Girona, Spain