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Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation

NCT06938919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Metal Industries Research & Development Centre

    collaborator UNKNOWN

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Kuang-Cheng Chan, M.D.,PhD. · Department of Anesthesiology, National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2025-11-13
Completion
2025-11-13

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938919 on ClinicalTrials.gov