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

NCT07563075 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang University

Phase

Not applicable

Started

2026-04-01

Last updated

2026-05-01

Condition(s) studied

HypoxemiaPneumoniaPulmonary Neoplasm

Investigational drug(s) / intervention(s)

High-flow nasal cannulaRegular Nasal Cannula

High-flow nasal cannula: Using High-flow nasal cannula oxygenation

Regular Nasal Cannula: Using regular nasal cannula for oxygenation

Study summary

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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

6 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

The incidence of hypoxemia — Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 \< 90% for \<60 s

Trial sites (4)

Facility	City	Region
Children's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
Children's Hospital of Chongqing Medical University	Chongqing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563075 on ClinicalTrials.gov ↗ ← All trials in China