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

Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Hypoxemia; Pulmonary Neoplasm
• Intervention / Treatment: Device: Regular Nasal Cannula; Device: High-flow nasal cannula

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diansan Su; Phone Number: +86 18616514088; Email: diansansu@yahoo.com
• Study Contact Backup: Name: Mingxia Xu; Phone Number: +86 13516713435; Email: xumingxia@zju.edu.cn

Study Locations

• China
  • Chongqing, China
    • Children's Hospital of Chongqing Medical University
    • Contact: Ping Xu
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Diansan Su; Phone Number: +86 18616514088; Email: diansansu@yahoo.com
    • Hangzhou, Zhejiang, China, 310000
      • Children's Hospital, Zhejiang University School of Medicine
      • Contact: Yue Jin
    • Wenzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Han Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flow nasal cannula Group	Device: High-flow nasal cannula; Using High-flow nasal cannula oxygenation
Active Comparator: Regular Nasal Cannula Group	Device: Regular Nasal Cannula; Using regular nasal cannula for oxygenation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of sub-clinical respiratory depression	90% ≤ SpO2 < 95%	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia	SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Adverse Events (Excluding Respiratory-Related)	Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Other Respiratory-Related Adverse Events		Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of emergence delirium in pediatric anesthesia	Incidence of emergence delirium in pediatric anesthesia- defined as a Pediatric Anesthesia Emergence Delirium scale score ≥10. Unit of measure: percentage of patients (%).	Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Length of stay in the Post-Anesthesia Care Unit (PACU)	Time from PACU admission until discharge criteria are met (modified Aldrete score ≥9). Unit of measure: minutes.	Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Study Chair: Diansan Su, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Bronchoscopy; Sedation; Hypoxemia; High-flow nasal cannula
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lung Neoplasms; Pneumonia; Hypoxia
• Other Study ID Numbers: ZJU2025C226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No