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

Not Applicable

• Conditions: Corona Virus Infection; ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2; Oxygen Deficiency
• Interventions: Device: Oxygen theraphy with mask with reservoir; Device: Oxygen theraphy with high flow nasal cannule

• Registration Number: NCT05197686
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-18
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Last Update Submitted: 2022-01-18
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COT	Oxygen theraphy with mask with reservoir	-
HFNC	Oxygen theraphy with high flow nasal cannule	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oxygen Therapy Sector of Temporary Hospital; 🇵🇱 Szczecin, Zachodniopomorskie, Poland