Clinical trial NCT05809089: HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Official title: Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 .

Primary outcomes:
measure: The rate of intubation among participant
timeFrame: within 72 hours after admission
Secondary outcomes:
measure: Improvement of respiratory exchanges compared to baseline
timeFrame: hospital admission until the achievement of clinical stability (72 hours)
measure: Dyspnea
timeFrame: hospital admission until the achievement of clinical stability (72 hours)
measure: Mortality rate
timeFrame: at 28 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Doaa Magdy Eid
Study officials:
affiliation: Assiut University
name: ahmed metwaly, dectorate
role: PRINCIPAL_INVESTIGATOR
References: