HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

NCT05809089 | Completed DMC

• 1 other identifier: 04355751
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement of respiratory exchanges compared to baseline

  hospital admission until the achievement of clinical stability (72 hours)

• Dyspnea

  hospital admission until the achievement of clinical stability (72 hours)

• Mortality rate

  at 28 days

Study Arms (2)

(High flow nasal cannula (HFNC)

ACTIVE COMPARATOR

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

Device: High flow nasal cannula (HFNC)

Noninvasive ventilation (NIV)

ACTIVE COMPARATOR

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

Device: Noninvasive ventilation (NIV)

Interventions

High flow nasal cannula (HFNC) DEVICE

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.

(High flow nasal cannula (HFNC)

Noninvasive ventilation (NIV) DEVICE

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

Noninvasive ventilation (NIV)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Doaa Magdy Eid

Asyut, Egypt

Location

Related Publications (1)

• Magdy DM. Outcome of Early Initiation of High-flow Nasal Oxygen Therapy among Pneumonia Patients Presenting with Acute Hypoxemic Respiratory Failure. Indian J Crit Care Med. 2024 Aug;28(8):753-759. doi: 10.5005/jp-journals-10071-24769. Epub 2024 Jul 31.

  PMID: 39239186 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• ahmed metwaly, dectorate

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate proffessour

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 12, 2023
• Study Start: November 20, 2020
• Primary Completion: January 20, 2023
• Study Completion: February 20, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)