Clinical Trial

Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation

Completed
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-14.
Status change: Not Yet Recruiting → Completed 2026-01-26
Trial Details
NCT Number NCT06938919
Lead Sponsor National Taiwan University Hospital
Collaborators: Metal Industries Research & Development Centre
Conditions Gastrointestinal Endoscope, Endoscopic Retrograde Cholangiopancreatogram (ERCP)
Enrollment 200 participants
Start Date 2025-05-29
Primary Completion 2025-11-13 (estimated)
Study Completion 2025-11-13 (estimated)
Updated on ClinicalTrials.gov 2026-01-28