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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04668196

Collaborator

Barcelona Institute for Global Health (Other)

367

Enrollment

Locations

8.1

Actual Duration (Months)

36.7

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Acute Respiratory Failure Corona Virus Infection	Device: High-flow nasal cannula treatment Device: Continuous positive airway pressure (CPAP) treatment Device: Noninvasive ventilation treatment

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 Design

Study Type:

Observational

Actual Enrollment :

367 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 22, 2020

Actual Primary Completion Date :

Jan 25, 2021

Actual Study Completion Date :

Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
High-flow nasal cannula treatment	Device: High-flow nasal cannula treatment Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy
Continuous positive airway pressure (CPAP) treatment	Device: Continuous positive airway pressure (CPAP) treatment Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy
Noninvasive ventilation treatment	Device: Noninvasive ventilation treatment Standard operating procedures represented by noninvasive ventilation treatment

Arm

Intervention/Treatment

High-flow nasal cannula treatment

Device: High-flow nasal cannula treatment

Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy

Continuous positive airway pressure (CPAP) treatment

Device: Continuous positive airway pressure (CPAP) treatment

Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy

Noninvasive ventilation treatment

Device: Noninvasive ventilation treatment

Standard operating procedures represented by noninvasive ventilation treatment

Outcome Measures

Primary Outcome Measures

Treatment failure [28 days within noninvasive respiratory support initiation]
Death or endotracheal intubation

Secondary Outcome Measures

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]
Duration of hospital stay [Until 28 days from noninvasive respiratory support initiation]
Time between admission and discharge from hospital or death in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	Hospital General de Granollers	Granollers	Barcelona	Spain	08402
3	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona	Spain
4	Fundació Althaia	Manresa	Barcelona	Spain	08243
5	Corporació Sanitària Parc Taulí	Sabadell	Barcelona	Spain	08208
6	Hospital Universitari Mútua Terrassa	Terrassa	Bardelona	Spain	08221
7	Hospital del Mar, Parc de Salut Mar	Barcelona		Spain	08003
8	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
9	Hospital Vall d'Hebron	Barcelona		Spain	08035
10	Hospital Dr.Josep Trueta	Girona		Spain	17007

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute
Barcelona Institute for Global Health

Investigators

Study Chair: Júlia Sampol, MD, Hospital Universitari Vall d'Hebron Research Institute
Principal Investigator: Sergi Marti, MD PhD, Hospital Universitari Vall d'Hebron Research Institute