HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

Assiut University

Status: Completed

Conditions: Pneumonia

Treatments: Device: High flow nasal cannula (HFNC); Device: Noninvasive ventilation (NIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT05809089

04355751

Details and patient eligibility

About

High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).

To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.

Full description

• Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
• The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.

Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
• The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.

Exclusion criteria

• Patients requiring emergency intubation,
• Recent esophageal, facial, or cranial trauma or surgery,
• Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less),
• Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
• Tracheotomy or other upper airway disorders,
• Active upper gastrointestinal bleeding, and
• Inability to clear respiratory secretions .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

(High flow nasal cannula (HFNC)

Active Comparator group

Description:

This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it.

Treatment:

Device: High flow nasal cannula (HFNC)

Noninvasive ventilation (NIV)

Active Comparator group

Description:

This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it.

Treatment:

Device: Noninvasive ventilation (NIV)