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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Lower mortality in HFNC group
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Groups are designed by web randomizer.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
Lower mortality in HFNC group
Time Frame: 6 months
Lower percent of intubation in HFNC group
Time Frame: 6 months
Shorter time of hospitalization in HFNC group
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported