NCT06938919

Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Endoscope
• Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Interventions

Type	Name	Description
DEVICE	routine care without electronic respiratory sound monitoring system	Maintain heart rate between 50-100 bpm; maintain systolic blood pressure between 90-160 mmHg; maintain SpO2 above 94%.
DEVICE	routine care with electronic respiratory sound monitoring system	Maintain heart rate between 50-100 bpm; maintain systolic blood pressure between 90-160 mmHg; maintain SpO2 above 94%; and refer to the following electronic breath sound abnormalities to maintain sedation depth: Maintain respiratory rate (RR) at 12-20 bpm; avoid partial airway obstruction

Timeline

• Start date: 2025-05-29
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2025-04-22
• Last updated: 2026-01-28

Locations

1 site across 1 country: Taiwan