HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

NCT ID: NCT05809089

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-02-20

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.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

(High flow nasal cannula (HFNC)

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

Group Type: ACTIVE_COMPARATOR

High flow nasal cannula (HFNC)

Intervention Type: 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.

Noninvasive ventilation (NIV)

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

Group Type: ACTIVE_COMPARATOR

Noninvasive ventilation (NIV)

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Magdy Eid

associate proffessour

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed metwaly, dectorate

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Doaa Magdy Eid

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39239186 (View on PubMed)

Other Identifiers

04355751

Identifier Type: -

Identifier Source: org_study_id