NCT07451704

IPI-Guided Monitoring for Oxygen Desaturation in ERCP

IPI-Guided Monitoring Prevents Oxygen Desaturation During ERCP Under Moderate Sedation: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Merve Gökçe · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Respiratory Depression
• Oxygen Desaturation
• Hypoxemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IPI GROUP	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.
DIAGNOSTIC_TEST	CONTROL GROUP	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.

Timeline

• Start date: 2019-10-18
• Primary completion: 2020-10-05
• Completion: 2020-10-05
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)