IPI-Guided Monitoring for Oxygen Desaturation in ERCP (IPITrail)

March 2, 2026 updated by: Merve Gökçe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Görükle
      • Bursa, Görükle, Turkey (Türkiye), 16100
        • Bursa Uludağ University Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years,
  • Scheduled for elective ERCP,
  • ASA physical status I-IV
  • Ability to provide written informed consent

Exclusion Criteria:

  • Age <18 years
  • ASA physical status ≥V
  • Pregnancy or suspected pregnancy
  • Known allergy to study sedative agents
  • Obstructive or restrictive pulmonary disease
  • Pre-procedural supplemental oxygen therapy or non-invasive ventilation
  • Predicted difficult airway
  • Pre-procedural systolic blood pressure <90 mmHg
  • Pre-procedural heart rate <60 beats/min
  • Emergency ERCP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPI GROUP
Standard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds.
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.
Active Comparator: CONTROL GROUP
Standard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Oxygen Desaturation
Time Frame: During the ERCP procedure
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypoxemia
Time Frame: During the ERCP procedure
Occurrence of hypoxemia defined as SpO₂ < 90% during the ERCP procedure.
During the ERCP procedure
Incidence of Apnea
Time Frame: During the ERCP procedure
Occurrence of apnea detected by capnography during the procedure
During the ERCP procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merve Gökçe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Actual)

October 5, 2020

Study Completion (Actual)

October 5, 2020

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-ERCP-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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