NCT05510388Unknown不适用
High-flow Nasal Cannula Oxygenation Reduces the Incidence of Hypoxia During Gastroscopy or Colonoscopy Sedated With Propofol in High-risk Patients: a Multi Central Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 18 to 80, both sexes
- •Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
- •18 kg/m2<BMI<28kg/m2
- •The anticipated operation time of the procedure shall be less than 30min.
- •Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
排除标准
- •Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
- •Patients diagnosed POCD
- •Patients clearly identified difficult airway
- •Patients with mechanical ventilation
- •Patients with acute respiratory infection and asthma
- •Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
- •Patients with aortic stenosis and carotid stenosis
- •Patients allergic to sedatives such as propofol
- •Patients without civil capacity such as cognitive dysfunction
研究组 & 干预措施
High-flow nasal cannula oxygenation group
Experimental
干预措施: High-flow nasal cannula oxygenation (Device)
Regular nasal cannula oxygenation group
Active Comparator
干预措施: Regular nasal cannula oxygenation (Device)
结局指标
主要结局
The incidence of hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Hypoxia refers to 75%≤SpO2\<90%,\<60S
次要结局
- Complications related to high-flow nasal cannula(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- The incidence of subclinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Other adverse events evaluated by the tool of World SIVA(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With PropofolTuberculous EndometritisSubseptate UterusEndometritisEndometrial PolypsNCT05049395RenJi Hospital960
Unknown
不适用
Effect of High-flow Nasal Oxygen on Extubation OutcomeCOPDCongestive Heart FailureRespiratory FailureNCT02290548Mackay Memorial Hospital400
Unknown
不适用
The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric PatientsBronchusTumorForeign BodiesStenosis of TracheaNCT03905733Yonsei University20
已完成
不适用
Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical PatientsPost-operative Pulmonary ComplicationsNCT03024112University of Colorado, Denver51
已完成
不适用
Apneic Oxygenation Via Nasal Cannulae Prevents Arterial HypoxemiaHypoxiaNCT00782977University of Manitoba90