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NCT07563075Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
430 (estimated)
First submitted
29 Mar 2026
Start date
1 Apr 2026
Primary completion date
31 Mar 2027
Lead sponsor
Zhejiang University
NCT number
NCT07563075

What you commit to

  • Study type: Interventional
  • Planned participants: 430
  • From 1 Apr 2026 to the primary completion date, 31 Mar 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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,
  • Other conditions deemed unsuitable by the investigator.

Other

  • preoperative SpO₂ \< 95% on room air,
  • Already sedated and tracheally intubated,
  • Multiple traumatic injuries,
  • Current participation in another clinical trial,

Who the study is looking for

  • 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.

Age in the registry: 1 year to 6 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Children's Hospital, Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The Second Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.