HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Device: Noninvasive ventilation (NIV); Device: High flow nasal cannula (HFNC)

• Registration Number: NCT05809089
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2023-01-20
• Study Completion: 2023-02-20
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 .

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation (NIV)	Noninvasive ventilation (NIV)	This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it.
(High flow nasal cannula (HFNC)	High flow nasal cannula (HFNC)	This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it.

Primary Outcome Measures

Name	Time	Method
The rate of intubation among participant	within 72 hours after admission	The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 \< 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency \> 40/min)

Secondary Outcome Measures

Name	Time	Method
Improvement of respiratory exchanges compared to baseline	hospital admission until the achievement of clinical stability (72 hours)	Evaluation of oxygenation (paO2 in mmHg )and hypercapnea (Pa Co2 in mmHg )using arterial blood gas )
Dyspnea	hospital admission until the achievement of clinical stability (72 hours)	Borg dyspnea scale
Mortality rate	at 28 days	Patient died after reintubation

Trial Locations

Locations (1)

Doaa Magdy Eid; 🇪🇬 Assiut, Egypt