NCT04500392招募中不适用
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing gastrointestinal endoscopes
- •age≥18 years old and ≤70 years old
- •patients or family members signed informed consent form
- •ASA classification I-II
- •BMI≥ 28kg/m²
排除标准
- •Coagulation disorders or a tendency of nose bleeding;
- •An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
- •Severe aortic stenosis or mitral stenosis;
- •Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
- •Acute myocardial infarction in the last 6 months;
- •Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;
- •Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
- •Increased intracranial pressure;
- •ASA classification Ⅲ-Ⅳ ;
- •Mouth, nose, or throat infection;
- •Liver and kidney disease
- •Fever, defined as core body temperature > 37.5℃;
- •Pregnancy, breastfeeding or positive pregnancy test;
- •Emergency procedure;
- •Patients or family members refused to participate
- •Mental disorders and people without civil capacity
研究组 & 干预措施
Control group
Active Comparator
Oxygen(up to 6L/min) supplied with a regular nasal catheter
干预措施: Regular nasal cannula (Device)
High-flow nasal cannula group
Experimental
Oxygen(up to 60L/min) supplied with high-flow nasal cannula
干预措施: High-flow 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]
(75% ≤ SpO2 \< 90% for \<60 s)
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)
- Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.(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)
研究者
diansan su
Vice Chair of the Department of Anesthesiology
RenJi Hospital
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Nasal Mask Kit in Gastrointestinal EndoscopyGastric PolypColon PolypHypoxiaGastric CancerEsophageal CancerColon CancerNCT05405530RenJi Hospital1,204
已完成
不适用
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly PatientsHypoxiaGastric PolypColon PolypGastric CancerEsophageal CancerColon CancerNCT05030870RenJi Hospital1,800
已完成
不适用
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by PropofolHypoxiaEsophagus CancerAdverse EventGastric CancerNCT03332433RenJi Hospital2,034
招募中
不适用
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy ProcedureGastric PolypHypoxiaEsophageal CancerColon CancerNCT06081647RenJi Hospital1,200
进行中（未招募）
不适用
Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort StudyHypoxiaNCT06710613Fengli Liu900