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New oxygen mask may prevent breathing dips during colonoscopy

NCT ID NCT05754255

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to see if using a special nasal mask that provides positive airway pressure (PAP) during colonoscopy sedation could reduce the frequency, length, and severity of low oxygen levels compared to standard oxygen through a nasal cannula. The study planned to enroll high-risk patients (such as those with obesity or sleep apnea) undergoing colonoscopy. However, the study was withdrawn before any participants were enrolled.

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.

Expected to start

Sep 2023

An estimate. Start dates often move.

Expected to finish

Jun 2024

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥18 years 2. Outpatients undergoing colonoscopy. 3. American Society of Anesthesiology (ASA) Physical Status I-III 4. BMI ≥35 kg/m2, documented obstructive sleep apnea or BMI\>30 with STOP-BANG score ≥3 5. Written informed consent Exclusion Criteria: 1. Inpatient status 2. Active Congestive Heart Failure Exacerbation 3. Untreated ischemic heart disease 4. Acute exacerbation of respiratory disorders, including COPD and asthma 5. Emergent procedures 6. Pregnancy 7. Previous enrollment in this study 8. Inability to provide informed consent. 9. Additional medical testing planned for the same day. 10. History of allergic reaction to propofol 11. History of allergic reaction to polypropylene or PVC. 12. Tracheostomy 13. Supra-glottic or sub-glottic tumor 14. Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon). 15. Known obstructing colon tumor, lesion, or stricture 16. Previous colon surgery (excluding anal surgery) 17. Active GI bleeding (hematochezia or melena during procedure preparation) 18. Large polyp (\> 2cm) removal 19. Previous failed or unsuccessfully completed colonoscopy.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Colonoscopy Positive-pressure respiration

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

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