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Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05759832
Enrollment
160
Registered
2023-03-08
Start date
2023-04-01
Completion date
2025-07-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen

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.

Interventions

DEVICEModified HFNC oxygen therapy

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.

DEVICENon-rebreathing reservoir mask

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%.

Sponsors

Affiliated Hospital of Qinghai University
CollaboratorOTHER
Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Need to increase ventilatory supportWithin 24 hours after bronchoscopyThe 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

MeasureTime frameDescription
A hierarchy of escalated respiratory support forms based on clinical severityWithin 24 hours after bronchoscopyA 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026