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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Respiratory DepressionOxygen DesaturationHypoxemia

Keywords

Integrated Pulmonary IndexERCPSEDATİONAİRWAY MANGEMENTCAPNOGRAPHYRESPİRATORY

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the ERCP procedure

Secondary Outcomes (2)

  • Incidence of Hypoxemia

    During the ERCP procedure

  • Incidence of Apnea

    During the ERCP procedure

Study Arms (2)

IPI GROUP

EXPERIMENTAL

Standard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds.

Diagnostic Test: IPI GROUP

CONTROL GROUP

ACTIVE COMPARATOR

Standard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters.

Diagnostic Test: CONTROL GROUP

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.

IPI GROUP
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.

CONTROL GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ University Faculty of Medicine Hospital

Bursa, Görükle, 16100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Parallel Assignment
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 5, 2026

Study Start

October 18, 2019

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

TU(1)