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临床试验/NCT07489157
NCT07489157尚未招募不适用

Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2026年3月27日最近更新:
适应症

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

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

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiqi Wang

Dr

Chinese PLA General Hospital

研究点 (1)

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