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Clinical Trials/NCT05809089
NCT05809089
Completed
Not Applicable

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

Assiut University1 site in 1 country200 target enrollmentNovember 20, 2020
ConditionsPneumonia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Assiut University
Enrollment
200
Locations
1
Primary Endpoint
The rate of intubation among participant
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
February 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doaa Magdy Eid

associate proffessour

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The rate of intubation among participant

Time Frame: 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 Outcomes

  • 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 Sites (1)

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