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Completed

NCT Number: NCT05809089

HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doaa Magdy Eid

Asyut, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

High flow nasal cannula (HFNC)

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)

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

Primary outcomes

  1. 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

  1. Improvement of respiratory exchanges compared to baseline

    Time frame: hospital admission until the achievement of clinical stability (72 hours)

    Evaluation of oxygenation (paO2 in mmHg )and hypercapnea (Pa Co2 in mmHg )using arterial blood gas )

  2. Dyspnea

    Time frame: hospital admission until the achievement of clinical stability (72 hours)

    Borg dyspnea scale

  3. Mortality rate

    Time frame: at 28 days

    Patient died after reintubation

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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