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New oxygen mask may prevent low oxygen during ERCP

NCT ID NCT06681558

Symptom relief Sponsor: Kocaeli City Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special oxygen mask that covers the mouth and nose works better than a standard nasal cannula to prevent low oxygen levels during ERCP, a scope procedure for the bile duct. Researchers enrolled 150 adults aged 18-75 and measured how often oxygen levels dropped below 90%. The goal is to find a safer way to deliver oxygen during this procedure.

What this could mean

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

Active substance
procedural oxygen mask
What this could lead to
If the mask works better, it could become a standard way to prevent low oxygen during ERCP, making the procedure safer.
What could go wrong
This is a small, completed study with 150 people, so results may not apply to everyone. The mask might not reduce low oxygen episodes significantly.

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

150 people

The number who actually took part.

Started

Nov 2024

Finished

Feb 2025

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 to 75 years

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: * Aged 18-75 years * American Society of Anesthesiologists (ASA) classification of 1-2-3 * Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit Exclusion Criteria: * Patients who refuse to participate in the study * Patients with allergies to ketamine, propofol, or midazolam * Patients diagnosed with psychiatric disorders * Patients with a body mass index (BMI) \>30 kg/m² * Patients with cognitive impairment, dementia, or communication issues * Pregnant patients or those in the postpartum period * Patients diagnosed with sleep apnea syndrome * History of intubation within the last 3 months * History of lower respiratory tract infection within the last 3 months * History of intensive care unit admission within the last 3 months * Patients with a tracheostomy * Patients with a history of tracheostomy * Patients who are oxygen-dependent due to a medical condition * Patients with lung cancer or who have undergone surgery on their lungs * Patients with asthma, COPD, or interstitial lung diseases * Patients with uncontrolled hypertension (BP \>180/110) * Patients receiving home care

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

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

Hypoxemia

Contacts and locations

Locations

  • Kocaeli City Hospital

    Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.