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| Name | Class |
|---|---|
| Metal Industries Research & Development Centre | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | routine care |
|
| Experimental | Experimental | routine care combine with electronic respiratory sound monitoring system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| routine care without electronic respiratory sound monitoring system | Device | Maintain heart rate between 50-100 bpm; maintain systolic blood pressure between 90-160 mmHg; maintain SpO2 above 94%. |
| Measure | Description | Time Frame |
|---|---|---|
| Desaturation | Incidence and duration of SpO2< 94% | during the procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 Questionnaire | QoR-15 Questionnaire | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuang-Cheng Chan, M.D.,PhD. | Department of Anesthesiology, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Taipei, Taiwan | Taipei | Taiwan |
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| routine care with electronic respiratory sound monitoring system | Device | 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 |
|
| during the procedure |