Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07451704
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:
NCT07451704
Study Brief:
Protocol Section:
NCT07451704