Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.

Study Overview
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Brief Summary
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The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. However, there have been reports in the literature that early initiation of high-flow oxygen therapy with a nasal cannula is associated with better prognosis. The study we perform is intended to provide reliable evidence for confirmation this hypothesis.

Official Title
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Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia: Prognosis and Impact on the Respiratory and Cardiovascular Systems.

Conditions
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Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency

Intervention / Treatment
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* Device: Oxygen theraphy with high flow nasal cannule
* Device: Oxygen theraphy with mask with reservoir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test [allowed in Poland, with sensitivity ≥90 and specificity ≥97]); Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin; Pneumonia during SARS-CoV2 infection; ARDS (PaO 2 / FiO 2 ratio ≤300); Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 < 92%; TNo current indications for treatment in the ICU; Permisson of the patient. Exclusion Criteria: Probable lack of cooperation with patient; Severe Disease disease, eg generalized neoplastic disease; Concomitant pulmonary diseases (eg, fibrosis lungs); Respiratory acidosis - pH <7.3 with pCO2> 50 mmHg; Disturbances of consciousness - GCS < 12;

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC<br> | Device: Oxygen theraphy with high flow nasal cannule<br>* Oxygen theraphy with high flow nasal cannule<br>|
| Active Comparator: COT<br> | Device: Oxygen theraphy with mask with reservoir<br>* Oxygen theraphy with mask with reservoir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower mortality in HFNC group |  | 6 months | 
| Lower percent of intubation in HFNC group |  | 6 months | 
| Shorter time of hospitalization in HFNC group |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.