Clinical trial NCT04668196: Noninvasive Respiratory Support in COVID-19 (CATCOVID-AIR)
Official title: Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Barcelona Institute for Global Health
First posted: 2020-12-16
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment failure
timeFrame: 28 days within noninvasive respiratory support initiation
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days within noninvasive respiratory support initiation
measure: Hospital mortality
timeFrame: Until 28 days from noninvasive respiratory support initiation
measure: Endotracheal intubation
timeFrame: 28 days within noninvasive respiratory support initiation
measure: Duration of hospital stay
timeFrame: Until 28 days from noninvasive respiratory support initiation
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Manresa
country: Spain
facility: Fundació Althaia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
state: Bardelona
city: Barcelona
country: Spain
facility: Hospital del Mar, Parc de Salut Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Dr.Josep Trueta
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Júlia Sampol, MD
role: STUDY_CHAIR
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Sergi Marti, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.