Electronic Respiratory Sound Monitoring System in Gastrointestinal Endoscopic Sedation

National Taiwan University

Status: Completed

Conditions: Gastrointestinal Endoscope; Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Treatments: Device: routine care with electronic respiratory sound monitoring system; Device: routine care without electronic respiratory sound monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT06938919

202409073DINC

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Control group

Active Comparator group

Description:

routine care

Treatment:

Device: routine care without electronic respiratory sound monitoring system

Experimental

Experimental group

Description:

routine care combine with electronic respiratory sound monitoring system

Treatment:

Device: routine care with electronic respiratory sound monitoring system