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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2022-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Groups are designed by web randomizer.

Study Groups

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HFNC

Group Type EXPERIMENTAL

Oxygen theraphy with high flow nasal cannule

Intervention Type DEVICE

Oxygen theraphy with high flow nasal cannule

COT

Group Type ACTIVE_COMPARATOR

Oxygen theraphy with mask with reservoir

Intervention Type DEVICE

Oxygen theraphy with mask with reservoir

Interventions

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Oxygen theraphy with high flow nasal cannule

Intervention Type DEVICE

Oxygen theraphy with mask with reservoir

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No