Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:03 AM
Study NCT ID:
NCT07451704
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPI-Guided Monitoring for Oxygen Desaturation in ERCP
Sponsor:
Merve Gökçe
Organization:
Study Overview
Official Title:
IPI-Guided Monitoring Prevents Oxygen Desaturation During ERCP Under Moderate Sedation: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPITrail
Brief 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: