HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Device: High flow nasal cannula (HFNC); Device: Noninvasive ventilation (NIV)

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Doaa Magdy Eid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Noninvasive ventilation (NIV); This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it.	Device: Noninvasive ventilation (NIV); Patients initiated NIV; Inspiratory positive airway pressure (IPAP) was initiated at 10-12 cmH2O, and expiratory positive airway pressure (EPAP) started at 4-5 cmH2O. FIO2 was adjusted to maintain SpO2 ≥ 90%. The same protocol as done in HFNC, patient will be evaluated every 8 hours and discontinued the device and returned back to the device for re- evaluation within 72 hours
Active Comparator: (High flow nasal cannula (HFNC); This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it.	Device: High flow nasal cannula (HFNC); High-flow nasal cannula device was utilized. Humidifier temperature was set at 37°C via large-bore bi-nasal prongs, and inspired oxygen (FiO2) was adjusted to maintain oxygen saturation by pulse oximetry (SpO2) ≥ 90%.The flow was initially set at 10 L/min and titrated upward in 5 L/min steps until patients experienced discomfort. Patient will be evaluated every 8 hours and discontinued the device for eating, drinking and coughing up secretion and returned back to the device for 72 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of intubation among participant	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)	within 72 hours after admission

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: ahmed metwaly, dectorate, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Pneumonia
• Other Study ID Numbers: 04355751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No