Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 试验地点
- 4
- 主要终点
- The incidence of hypoxemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
High-flow nasal cannula Group
干预措施: High-flow nasal cannula (Device)
Regular Nasal Cannula Group
干预措施: Regular Nasal Cannula (Device)
结局指标
主要结局
The incidence of hypoxemia
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 \< 90% for \<60 s
次要结局
- 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)
研究者
Diansan Su
Chief Physician,Researcher
Zhejiang University