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Completed

NCT Number: NCT07451704

IPI-Guided Monitoring for Oxygen Desaturation in ERCP

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.

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Key information

Conditions

Respiratory Depression Hypoxemia Hypoxia Oxygen Desaturation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludağ University Faculty of Medicine Hospital

Bursa, Görükle, 16100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of Hypoxemia

    Time frame: During the ERCP procedure

    Occurrence of hypoxemia defined as SpO₂ < 90% during the ERCP procedure.

  2. Incidence of Apnea

    Time frame: During the ERCP procedure

    Occurrence of apnea detected by capnography during the procedure

Sponsors and collaborators

Lead sponsor

Merve Gökçe

Other Gov

Registry information

Official study title

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

Acronym: IPITrail

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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