HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809089
• Other study ID #: 04355751
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: February 20, 2023

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Insufficiency

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Doaa Magdy Eid	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Dyspnea	Borg dyspnea scale	hospital admission until the achievement of clinical stability (72 hours)
Secondary	Mortality rate	Patient died after reintubation	at 28 days