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

NCT ID: NCT04668196

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-22

Study Completion Date

2021-01-25

Brief Summary

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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

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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.

Conditions

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Covid19 Acute Respiratory Failure Corona Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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High-flow nasal cannula treatment

High-flow nasal cannula treatment

Intervention Type DEVICE

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

Continuous positive airway pressure (CPAP) treatment

Continuous positive airway pressure (CPAP) treatment

Intervention Type DEVICE

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

Noninvasive ventilation treatment

Noninvasive ventilation treatment

Intervention Type DEVICE

Standard operating procedures represented by noninvasive ventilation treatment

Interventions

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High-flow nasal cannula treatment

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

Intervention Type DEVICE

Continuous positive airway pressure (CPAP) treatment

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

Intervention Type DEVICE

Noninvasive ventilation treatment

Standard operating procedures represented by noninvasive ventilation treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barcelona Institute for Global Health

OTHER

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Júlia Sampol, MD

Role: STUDY_CHAIR

Hospital Universitari Vall d'Hebron Research Institute

Sergi Marti, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron Research Institute

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital General de Granollers

Granollers, Barcelona, Spain

Site Status

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Fundació Althaia

Manresa, Barcelona, Spain

Site Status

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Hospital Universitari Mútua Terrassa

Terrassa, Bardelona, Spain

Site Status

Hospital del Mar, Parc de Salut Mar

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Dr.Josep Trueta

Girona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 35444251 (View on PubMed)

Other Identifiers

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PR(AG)265/2020

Identifier Type: -

Identifier Source: org_study_id

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