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This randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation.
Adults undergoing elective ERCP are randomized 1:1 to standard monitoring alone or standard monitoring plus visible IPI (SpO₂, respiratory rate, pulse rate, and EtCO₂). Sedation is standardized (midazolam, fentanyl, ketamine) with a target RASS of -3 and routine supplemental oxygen. Oxygen desaturation (>5% decrease in SpO₂ from baseline) during the procedure is the primary outcome. Secondary outcomes include hypoxemia (SpO₂ <90%), apnea, bradypnea, and the frequency of airway interventions (verbal-tactile stimulation, jaw-thrust, head-tilt).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPI GROUP | Experimental | Standard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds. |
|
| CONTROL GROUP | Active Comparator | Standard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI GROUP | Diagnostic Test | Real-time monitoring of SpO₂, respiratory rate, pulse rate, and end-tidal CO₂ using capnography with visible IPI values to guide airway interventions during ERCP under moderate sedation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Oxygen Desaturation | Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure. | During the ERCP procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypoxemia | Occurrence of hypoxemia defined as SpO₂ < 90% during the ERCP procedure. | During the ERCP procedure |
| Incidence of Apnea | Occurrence of apnea detected by capnography during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Uludağ University Faculty of Medicine Hospital | Bursa | Görükle | 16100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Parallel Assignment
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Parallel Assignment
| CONTROL GROUP | Diagnostic Test | Routine monitoring with ECG, non-invasive blood pressure, and pulse oximetry during ERCP under moderate sedation. IPI values are not displayed to the clinical team. |
|
| During the ERCP procedure |
| D013568 | Pathological Conditions, Signs and Symptoms |