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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Corona Virus Infection; Acute Respiratory Failure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 367

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08003
    • Hospital del Mar, Parc de Salut Mar
  • Girona, Spain, 17007
    • Hospital Dr.Josep Trueta
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Granollers, Barcelona, Spain, 08402
      • Hospital General de Granollers
    • Hospitalet de Llobregat, Barcelona, Spain
      • Hospital de Bellvitge
    • Manresa, Barcelona, Spain, 08243
      • Fundacio Althaia
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Bardelona
    • Terrassa, Bardelona, Spain, 08221
      • Hospital Universitari Mutua Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	Death or endotracheal intubation	28 days within noninvasive respiratory support initiation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Coronavirus Infection; Respiratory Failure; Noninvasive ventilation; Severe Acute Respiratory Syndrome; High-flow nasal cannula
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Respiratory Insufficiency
• Other Study ID Numbers: PR(AG)265/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No