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New monitor may prevent oxygen emergencies during ERCP

NCT ID NCT07451704

Knowledge-focused Sponsor: Merve Gökçe Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a monitor that tracks breathing and oxygen levels (called IPI) can prevent dangerous oxygen drops during ERCP, a procedure to examine the bile ducts. 80 adults having elective ERCP under moderate sedation were randomly assigned to either standard monitoring or IPI-guided monitoring. The goal was to see if the IPI monitor helps doctors catch breathing problems earlier and reduce oxygen desaturation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to safer sedation practices during ERCP by catching breathing problems early.
What could go wrong
This is a small, completed trial with 80 participants, so results may not apply broadly. The intervention is a monitoring tool, not a treatment, so benefits are limited to detection, not prevention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Oct 2019

Finished

Oct 2020

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hypoxia respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxemia Oxygen desaturation Respiratory depression

Contacts and locations

Locations

  • Bursa Uludağ University Faculty of Medicine Hospital

    Bursa, Görükle, 16100, Turkey (Türkiye)

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