Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy

Starting soon · Not applicable

Conditions studied: Hypoxemia, Pneumonia, Pulmonary Neoplasm

In brief

Due to children's lower oxygen reserves and higher oxygen consumption, sedation can easily lead to respiratory adverse events such as hypoxemia. It has been reported that the incidence of hypoxemia during pediatric bronchoscopy is high, highlighting that hypoxemia in pediatric painless bronchoscopy is an urgent problem requiring a solution. High-flow nasal cannula (HFNC) oxygen therapy delivers heated and humidified breathing gas with a precisely controllable oxygen concentration, at flow rates exceeding the patient's peak inspiratory flow, directly via unsealed nasal prongs. It is a simple, comfortable, effective, and non-invasive respiratory support method that has been widely adopted in clinical practice. However, the effectiveness of HFNC in pediatric sedation remains unclear. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxemia during sedated bronchoscopy in pediatric patients.

Key facts

Study ID

NCT07563075

Run by

Zhejiang University

People needed

430

Starts

2026-04-01

Expected to finish

2027-03-31

Last updated by the study team

2026-05-01

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1 year ≤ age ≤ 6 years,
• Weight ≥ 10 kg,
• Undergoing elective sedated bronchoscopy,
• Expected procedure duration ≤ 45 minutes,
• Written informed consent obtained from the subject's legal guardian.

You may not qualify if…

• preoperative SpO₂ < 95% on room air,
• Already sedated and tracheally intubated,
• Known history of pneumothorax, known congenital or acquired upper airway abnormalities (e.g., nasopharyngeal structural anomalies), or history of difficult airway,
• Coagulation disorders or predisposition to oral/nasal bleeding, mucosal injury, or space-occupying lesions,
• Severe cardiac insufficiency (< 4 METs), severe renal insufficiency (requiring dialysis), diagnosed severe hepatic insufficiency, Increased intracranial pressure, or ASA classification ≥ IV,
• Allergy to propofol or sufentanil,
• Multiple traumatic injuries,
• Current participation in another clinical trial,
• Other conditions deemed unsuitable by the investigator.

Where it is running

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Children's Hospital of Chongqing Medical University — Chongqing, China

Full record on ClinicalTrials.gov

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