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.
| Registry | NCT05197686 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Pomeranian Medical University Szczecin (Other) |
| Conditions | Corona Virus Infection, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, Oxygen Deficiency |
| Interventions | Oxygen theraphy with high flow nasal cannule, Oxygen theraphy with mask with reservoir (Device) |
| Dates | start 2022-01-18 (estimated), primary completion 2022-06-30 (estimated), completion 2022-12-31 (estimated), first posted 2022-01-19, last updated 2022-01-19 |
| Locations | 1 site in Poland |
Related Papers Related Patents Related Grants Related Experts
All trials for Corona Virus Infection All trials for ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 All trials of Oxygen theraphy with high flow nasal cannule All trials of Oxygen theraphy with mask with reservoir
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HFNC | Experimental | Device: Oxygen theraphy with high flow nasal cannule | |
| COT | Active comparator | Device: Oxygen theraphy with mask with reservoir |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test \[allowed in Poland, with sensitivity ≥90 and specificity ≥97\]); 2. Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin; 3. Pneumonia during SARS-CoV2 infection; 4. ARDS (PaO 2 / FiO 2 ratio ≤300); 5. Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 < 92%; 6. TNo current indications for treatment in the ICU; 7. Permisson of the patient. Exclusion Criteria: 1. Probable lack of cooperation with patient; 2. Severe Disease disease, eg generalized neoplastic disease; 3. Concomitant pulmonary diseases (eg, fibrosis lungs); 4. Respiratory acidosis - pH <7.3 with pCO2> 50 mmHg; 5. Disturbances of consciousness - GCS < 12;
| Facility | City | Country | Status |
|---|---|---|---|
| Oxygen Therapy Sector of Temporary Hospital | Szczecin, West Pomeranian Voivodeship | Poland |