Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

Not Applicable

Recruiting

• Conditions: High-flow Nasal Cannula Oxygen; Acute Hypoxemic Respiratory Failure

• Registration Number: NCT05759832
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-08
• Study Start: 2023-04-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need to increase ventilatory support	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: 1. Escalation to invasive mechanical ventilation (IMV); 2. Escalation to non-invasive ventilation (NIV); 3. Escalation to HFNC oxygen therapy; 4. 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 Outcome Measures

Name	Time	Method
A hierarchy of escalated respiratory support forms based on clinical severity	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.

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China