NCT05526339Unknown不适用
High-Flow Nasal Oxygenation Combined With Nasopharyngeal Airway Reduces The Incidence Of Hypoxia During Gastrointestinal Endoscopy Sedated With Propofol In Obese Patients: A Prospective, Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese 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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
- •Age ranging from 19 to 80, both male and female
- •Obese patients，BMI ≥ 28kg/m^2
- •Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
排除标准
- •Patients with acute respiratory infection in the last 2 weeks
- •Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
- •hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
- •Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
- •coagulation disorders or platelets < 100*10^9/L
- •Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets
- •Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
- •Participated in other clinical trials as a subject within 3 months
- •Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
- •Emergency procedure
- •Pregnant or breast-feeding women
- •Patients having procedures with planned tracheal intubation or laryngeal mask
- •Investigator considers the patients are inappropriate to participate in this trial
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
- 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)
- The incidence of other adverse events(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
研究者
研究点 (2)
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