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

NCT04668196 | Completed

• 1 other identifier: PR(AG)265/2020
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 10

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.

Conditions

Covid19; Acute Respiratory Failure; Corona Virus Infection

Keywords

Noninvasive ventilation; High-flow nasal cannula; Severe Acute Respiratory Syndrome; Respiratory Failure; Respiratory Tract Diseases; Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  Death or endotracheal intubation

  28 days within noninvasive respiratory support initiation

Secondary Outcomes (4)

• 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

• Duration of hospital stay

  Until 28 days from noninvasive respiratory support initiation

Study Arms (3)

High-flow nasal cannula treatment

Device: High-flow nasal cannula treatment

Continuous positive airway pressure (CPAP) treatment

Device: Continuous positive airway pressure (CPAP) treatment

Noninvasive ventilation treatment

Device: Noninvasive ventilation treatment

Interventions

High-flow nasal cannula treatment DEVICE

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

High-flow nasal cannula treatment

Continuous positive airway pressure (CPAP) treatment DEVICE

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

Continuous positive airway pressure (CPAP) treatment

Noninvasive ventilation treatment DEVICE

Standard operating procedures represented by noninvasive ventilation treatment

Noninvasive ventilation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID19 patients treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP, or noninvasive ventilation), initiated outside the intensive care unit.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (10)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Fundació Althaia

Manresa, Barcelona, 08243, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitari Mútua Terrassa

Terrassa, Bardelona, 08221, Spain

Location

Hospital del Mar, Parc de Salut Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Dr.Josep Trueta

Girona, 17007, Spain

Location

Related Publications (1)

• Marti S, Carsin AE, Sampol J, Pallero M, Aldas I, Marin T, Lujan M, Lalmolda C, Sabater G, Bonnin-Vilaplana M, Penacoba P, Martinez-Llorens J, Tarrega J, Bernadich O, Cordoba-Izquierdo A, Lozano L, Mendez S, Velez-Segovia E, Prina E, Eizaguirre S, Balana-Corbero A, Ferrer J, Garcia-Aymerich J. Higher mortality and intubation rate in COVID-19 patients treated with noninvasive ventilation compared with high-flow oxygen or CPAP. Sci Rep. 2022 Apr 20;12(1):6527. doi: 10.1038/s41598-022-10475-7.

  PMID: 35444251 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Respiratory Insufficiency; Respiratory Tract Diseases

Interventions

Continuous Positive Airway Pressure; Therapeutics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Júlia Sampol, MD

  Hospital Universitari Vall d'Hebron Research Institute

  STUDY CHAIR

• Sergi Marti, MD PhD

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 16, 2020
• Study Start: May 22, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

ES (10)