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

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05197686

Enrollment

100

Registered

2022-01-19

Start date

2022-01-18

Completion date

2022-12-31

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SARS-CoV2, COVID-19, HFNC, COT, Oxygen therapy.

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.

Interventions

DEVICEOxygen theraphy with high flow nasal cannule

Oxygen theraphy with high flow nasal cannule

DEVICEOxygen theraphy with mask with reservoir

Oxygen theraphy with mask with reservoir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Groups are designed by web randomizer.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame
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

Countries

Poland

Contacts

Primary ContactWojciech Witkiewicz

witkiewiczwojciech@gmail.com+48509082762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026