Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Zhejiang University
- Enrollment
- 430
- Locations
- 4
- Primary Endpoint
- The incidence of hypoxemia
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
High-flow nasal cannula Group
Intervention: High-flow nasal cannula (Device)
Regular Nasal Cannula Group
Intervention: Regular Nasal Cannula (Device)
Outcomes
Primary Outcomes
The incidence of hypoxemia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 \< 90% for \<60 s
Secondary Outcomes
- 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)
Investigators
Diansan Su
Chief Physician,Researcher
Zhejiang University