NCT05809089

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-11-20
• Primary completion: 2023-01-20
• Completion: 2023-02-20
• First posted: 2023-04-12
• Last updated: 2023-08-25

Locations

1 site across 1 country: Egypt