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Not yet recruiting NCT07563075

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

No phase Interventional Hypoxemia Pneumonia Pulmonary Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-flow nasal cannula, Regular Nasal Cannula.
Who it may be relevant to
Registry conditions: Hypoxemia, Pneumonia, Pulmonary Neoplasm. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device High-flow nasal cannula
    Using High-flow nasal cannula oxygenation
  • Device Regular Nasal Cannula
    Using regular nasal cannula for oxygenation

Primary outcome measures

  • The incidence of hypoxemia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (4)
  • The incidence of sub-clinical respiratory depression [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • The incidence of severe hypoxia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • Incidence of Other Adverse Events (Excluding Respiratory-Related) [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
  • Incidence of Other Respiratory-Related Adverse Events [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 4 centers
  • Children's Hospital, Zhejiang University School of Medicine — Hangzhou
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou
  • Children's Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT07563075 · ZJU2025C226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗