Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypoxemia | — | UNRESOLVED | — |
| Pneumonia | — | UNRESOLVED | — |
| Pulmonary Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-flow nasal cannula | Device | — | UNRESOLVED |
| Regular Nasal Cannula | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-flow nasal cannula Group
- interventionNames
- Device: High-flow nasal cannula
- type
- ACTIVE_COMPARATOR
- label
- Regular Nasal Cannula Group
- interventionNames
- Device: Regular Nasal Cannula
Primary outcomes (1)
- measure
- The incidence of hypoxemia
- timeFrame
- Patients will be followed for the duration of hospital stay, an expected average about 2 hours
- description
- 75% ≤ SpO2 \< 90% for \<60 s
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 6 Years
Show eligibility criteria text
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.
References
Publications (0)
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