Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
研究概览
简要总结
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.
详细描述
Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 <=94%) and desaturation events requiring intervention (SpO2<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight loss surgery patients undergoing preoperative upper endoscopy
- •BMI 40-60
排除标准
- •Pregnant patients
- •Previous weight loss surgery or stomach surgery
- •BMI > 60 and BMI < 40
- •Active smokers
- •Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
- •Lung disease, COPD asthma, cystic fibrosis, sarcoidosis
- •Baseline O2 saturation less than or equal to 94%
- •Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)
研究组 & 干预措施
Control
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
干预措施: Rescue non-invasive positive pressure ventilation through nasal mask (Device)
Control
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
干预措施: Secondary rescue maneuvers (Other)
Experimental
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
干预措施: Non-invasive positive pressure ventilation through nasal mask (Device)
Experimental
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
干预措施: Secondary rescue maneuvers (Other)
结局指标
主要结局
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
时间窗: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Percentage of Participants With an Oxygen Desaturation Event < 90%
时间窗: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Percentage of participants who develop a peripheral oxygen saturation event \< 90%.
次要结局
- Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV(3 minutes following a desaturation event < 90 %)
研究者
Makram Gedeon, MD
Medical director of bariatric surgery program, principal investigator
Bristol Hospital