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

NCT07563075 | Not Yet Recruiting

• 1 other identifier: ZJU2025C226
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hypoxemia; Pneumonia; Pulmonary Neoplasm

Keywords

Bronchoscopy; Hypoxemia; Sedation; Pediatric; High-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidence of sub-clinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of severe hypoxia

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• Incidence of Other Adverse Events (Excluding Respiratory-Related)

  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 Outcomes (2)

• Incidence of emergence delirium in pediatric anesthesia

  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)

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (2)

High-flow nasal cannula Group

EXPERIMENTAL

Device: High-flow nasal cannula

Regular Nasal Cannula Group

ACTIVE COMPARATOR

Device: Regular Nasal Cannula

Interventions

High-flow nasal cannula DEVICE

Using High-flow nasal cannula oxygenation

High-flow nasal cannula Group

Regular Nasal Cannula DEVICE

Using regular nasal cannula for oxygenation

Regular Nasal Cannula Group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (4)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 310000, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, China

Location

MeSH Terms

Conditions

Hypoxia; Pneumonia; Lung Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Diansan Su

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Diansan Su

CONTACT

+86 18616514088; diansansu@yahoo.com

Mingxia Xu

CONTACT

+86 13516713435; xumingxia@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Researcher

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-03

Locations

CN (4)