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NCT Number: NCT05759832

Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

Acute respiratory failure (AFR) is a serious condition that requires prompt and appropriate intervention to prevent further deterioration and improve outcomes. Bronchoscopy is a commonly used diagnostic and therapeutic procedure in patients with respiratory failure. However, traditional low-flow oxygen supplementation during bronchoscopy may not provide adequate oxygenation and ventilation, leading to complications and worsening of the patient's condition.

High-flow nasal cannula therapy has improved oxygenation and ventilation in critically ill patients, making it a promising alternative to traditional oxygen supplementation during bronchoscopy. The bronchoscope is passed through the nose during all procedures in our center. HFNC oxygen therapy is applied to both nostrils. The bronchoscope occupies one of the nares receiving oxygen therapy during bronchoscopy. As a result, the application of HFNC needs to be optimized. Therefore, the investigators designed a modified HFNC with a single cannula. However, limited data exist on the safety and efficacy of modified HFNC therapy in patients with respiratory failure undergoing bronchoscopy.

Therefore, the aim of this study is to evaluate the impact of modified HFNC therapy on the outcomes of undergoing bronchoscopy in patients with ARF. The findings of this study will contribute to understanding the role of modified HFNC therapy in managing ARF and inform clinical practice.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure High-flow Nasal Cannula Oxygen Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao-Yang Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years;
  • Respiratory failure defined as a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg;
  • Clinical indication for FB to diagnose or treat pulmonary disease.

Exclusion criteria

  • Pre-existing endotracheal intubation or tracheostomy;
  • Required immediate endotracheal intubation;
  • PaO2/FiO2 <150 mm Hg;
  • Platelet count <60 × 109/L;
  • History of myocardial infarction within the past 6 weeks;
  • Nasopharyngeal obstruction or blockage;
  • Presence of chest skin lesions contraindicating the application of electrical impedance tomography (EIT);
  • Intolerance to HFNC oxygen therapy.

Treatment and study plan

Modified HFNC oxygen therapy

Device

In the modified HFNC group, high-flow devices (AIRVOTM 2; Fisher & Paykel Healthcare, Auckland, New Zealand) were utilized for respiratory support. The nasal cannula used was a modified single nasal cannula.

Non-rebreathing reservoir mask

Device

In the non-rebreathing reservoir mask group, oxygen was delivered via a non-rebreathing reservoir mask during bronchoscopy. The oxygen flow was set to achieve a saturation of pulse oxygen > 90%.

Primary outcomes

  1. Need to increase ventilatory support

    Time frame: Within 24 hours after bronchoscopy

    The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria:

    • Escalation to invasive mechanical ventilation (IMV);
    • Escalation to non-invasive ventilation (NIV);
    • Escalation to HFNC oxygen therapy;
    • An increase in support parameters without changing the level of respiratory support: For NIV patients: a >20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a >20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a >50% increase in oxygen flow rate.

Secondary outcomes

  1. A hierarchy of escalated respiratory support forms based on clinical severity

    Time frame: Within 24 hours after bronchoscopy

    A hierarchical composite outcome, assessed in a fixed sequence: escalation to IMV, escalation to NIV, escalation to HFNO therapy, and an increase in support parameters without changing the level of respiratory support.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Affiliated Hospital of Qinghai University

Registry information

Official study title

Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Nov 21, 2025

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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