Endoscopic Retrograde Cholangiopancreatogram (ERCP), Gastrointestinal Endoscope
Conditions
Keywords
Electronic repiratory sound monitoring system, Gstrointestinal endoscopic sedation
Brief 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.
Interventions
DEVICEroutine 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%.
DEVICEroutine 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
National Taiwan University Hospital
Metal Industries Research & Development Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation | during the procedure | Incidence and duration of SpO2\< 94% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of airway management for desaturation | during the procedure | jaw thrust manuever, nasal airway insertion, mask ventilation |
| Total amount of anesthetics | during the procedure | Total amount of anesthetics used |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORKuang-Cheng Chan, M.D.,PhD.
Department of Anesthesiology, National Taiwan University Hospital
Outcome results
None listed