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临床试验/NCT06938919
NCT06938919已完成不适用

Impact of Implementing an Electronic Respiratory Sound Monitoring System for Quality Improvement in Gastrointestinal Endoscopic Sedation: A Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Desaturation

研究概览

简要总结

This study aims to evaluate the application of an electronic respiratory sound monitoring system during sedation for gastrointestinal endoscopy and to determine its effectiveness in improving sedation quality. Gastrointestinal endoscopy is a common medical procedure, but respiratory complications caused by sedation, such as hypoventilation and airway obstruction, are significant safety concerns. Traditional respiratory monitoring methods, such as end-tidal CO2 monitoring, are often unreliable due to difficulties in gas sampling during the procedure. In contrast, an electronic respiratory sound monitoring system can accurately capture tracheal breathing sounds and provide important parameters such as respiratory rate and airway obstruction ratio, helping clinicians avoid over-sedation. This study will conduct a randomized controlled trial with 120 participants, divided into a control group with conventional monitoring and an experimental group using the electronic respiratory sound monitoring system. The study will compare sedation dosage, airway complications, and recovery speed between the two groups, and further analyze the clinical value of the system's parameters. The findings of this study will contribute to improving the safety and precision of sedation during gastrointestinal endoscopy and provide evidence for future clinical guidelines.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who undergo routine colonoscopy plus gastroscopy or endoscopic retrograde cholangiopancreatography (ERCP) and require deep sedation

排除标准

  • •Pregnancy
  • •Patients diagnosed with sleep apnea or morbid obesity (BMI greater than 40 kg/m2)

研究组 & 干预措施

Control group

Active Comparator

routine care

干预措施: routine care without electronic respiratory sound monitoring system (Device)

Experimental

Experimental

routine care combine with electronic respiratory sound monitoring system

干预措施: routine care with electronic respiratory sound monitoring system (Device)

结局指标

主要结局

Desaturation

时间窗: during the procedure

Incidence and duration of SpO2\< 94%

次要结局

  • Incidence of airway management for desaturation(during the procedure)
  • Total amount of anesthetics(during the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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