High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of hypoxia
研究概览
简要总结
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia.
Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral 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
- None
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
- 是
入选标准
- •ASA class ≤Ⅲ
- •Visceral obesity（body mass index≥28 and BRI ≥5.46）
- •Patients who will undergo sedated gastroscopy
排除标准
- •Life-threatening heart disease or acute myocardial infarction within 6 weeks
- •Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
- •Upper respiratory tract infection
- •Presence of tracheostomy
- •Nasal or nasopharyngeal diseases
- •Coagulation disorders or a tendency of nose bleeding
- •Pregnancy
- •Recent (within 1 week) thoracic surgery
- •Emergent procedure or surgery
- •Allergy to drugs used during the procedure
- •Unwillingness to participate in the study
结局指标
主要结局
Incidence of hypoxia
时间窗: From sedation with propofol to the end of the gastroscopy
SpO2\<90%
次要结局
- Incidence of subclinical respiratory depression(From sedation with propofol to the end of the gastroscopy)
- Severe hypoxia(From sedation with propofol to the end of the gastroscopy)
- Serious cardiac events(Through gastroscopy completion, an average of 10-15 minutes)
- Serious adverse respiratory events(Through gastroscopy completion, an average of 10-15 minutes)