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

Pomeranian Medical University Szczecin

Status: Unknown

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

Treatments: Device: Oxygen theraphy with mask with reservoir; Device: Oxygen theraphy with high flow nasal cannule

Study type: Interventional

Funder types: Other

Identifiers

NCT05197686

KB-0012/58/2021

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

HFNC

Experimental group

Treatment:

Device: Oxygen theraphy with high flow nasal cannule

COT

Active Comparator group

Treatment:

Device: Oxygen theraphy with mask with reservoir