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

Study Overview
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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.

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

Conditions
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Covid19, Acute Respiratory Failure, Corona Virus Infection

Intervention / Treatment
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* Device: High-flow nasal cannula treatment
* Device: Continuous positive airway pressure (CPAP) treatment
* Device: Noninvasive ventilation treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive ventilation, High-flow nasal cannula, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Tract Diseases, Coronavirus Infection