Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- incidence of hypoxemia
研究概览
简要总结
Using Capnography for Safer Sedation in Painless Gastrointestinal Endoscopy
Why is this study important? For procedures like painless gastroscopy and colonoscopy, patients receive sedation to ensure comfort. However, traditional monitoring (like checking heart rate and blood oxygen levels) can only detect breathing problems after they have already caused a drop in oxygen. This delay can be risky, especially for elderly patients whose breathing function is naturally weaker. This study looks at a better way to monitor patients.
What is the new method? This study focuses on a technology called real-time end-tidal carbon dioxide (ETCO₂) monitoring, also known as capnography. It is a simple, non-invasive device that continuously measures the carbon dioxide a patient breathes out. This provides an early warning system for doctors, alerting them to breathing issues (like a pause in breathing or an airway blockage) much sooner than traditional monitors can.
What did the study find?
Based on extensive research and clinical experience both in China and internationally (including the US and Europe), integrating ETCO₂ monitoring into painless digestive endoscopy procedures leads to significant improvements in patient safety:
- Reduces Risks: It can decrease the occurrence of hypoxemia (dangerously low oxygen levels) by up to 31%.
- Early Detection: It detects breathing problems 17.6 times more often than relying on traditional observation alone, giving anesthesiologists crucial extra time (often seconds) to intervene before a patient's oxygen drops.
- Safer for Everyone: It is particularly effective in protecting high-risk groups, such as elderly patients and those with mild obesity.
- Better Outcomes: It helps reduce postoperative complications like nausea and vomiting, and can lead to faster recovery from anesthesia.
Value for Patients, Families, and Providers:
- For Patients & Families: This technology means a safer, more comfortable procedure with a lower risk of breathing complications. It provides peace of mind knowing your breathing is being watched continuously and carefully.
- For Healthcare Providers: It offers a clear, real-time picture of a patient's breathing status. This supports quicker, more confident clinical decisions, reduces workload, and helps establish a standardized, quantifiable safety protocol for non-operating room anesthesia, aligning with the World Health Organization's goals for safer surgery.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing gastroscopy and colonoscopy under intravenous anesthesia
排除标准
- •(Ⅰ) patients unable to wear the sampling device; (Ⅱ) patients with a pulse oximetry reading (SpO2) of less than 95% when breathing ambient air;(Ⅲ)central nervous system abnormalities; (Ⅳ)patients who do not consent to participate in the study;(Ⅴ)poor bowel preparation.
结局指标
主要结局
incidence of hypoxemia
时间窗: During gastrointestinal endoscopy
Incidence of SpO₂ \< 95%(%)
Duration of hypoxemia
时间窗: During gastrointestinal endoscopy
Duration of of SpO₂ \< 95%(seconds)
次要结局
- Incidence of movement(during gastrointestinal endoscopy)
研究者
Peiqi Wang
Dr
Chinese PLA General Hospital
