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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatogram (ERCP); Gastrointestinal Endoscope
• Intervention / Treatment: Device: routine care without electronic respiratory sound monitoring system; Device: routine care with electronic respiratory sound monitoring system

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital, Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; routine care	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%.
Experimental: Experimental; routine care combine with electronic respiratory sound monitoring system	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation	Incidence and duration of SpO2< 94%	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of airway management for desaturation	jaw thrust manuever, nasal airway insertion, mask ventilation	during the procedure
Total amount of anesthetics	Total amount of anesthetics used	during the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoR-15 Questionnaire	QoR-15 Questionnaire	24 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Metal Industries Research & Development Centre
• Investigators: Principal Investigator: Kuang-Cheng Chan, M.D.,PhD., Department of Anesthesiology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Actual): November 13, 2025
• Study Completion (Actual): November 13, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Electronic repiratory sound monitoring system; Gstrointestinal endoscopic sedation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: 202409073DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No