IPI-Guided Monitoring for Oxygen Desaturation in ERCP

Merve Gökçe80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Respiratory Depression Oxygen Desaturation Hypoxemia

Interventions

IPI GROUPDIAGNOSTIC_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 GROUPDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bursa Uludağ University Faculty of Medicine Hospital

Bursa, Görükle, Turkey (Türkiye)

Outcomes

Primary Outcomes

Incidence of Oxygen Desaturation

Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure.

Time frame: During the ERCP procedure

Secondary Outcomes

Incidence of Hypoxemia

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

Time frame: During the ERCP procedure

Incidence of Apnea

Occurrence of apnea detected by capnography during the procedure

Time frame: During the ERCP procedure

Data from ClinicalTrials.gov

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