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3D-Printed device could make breathing tubes safer for obese patients

NCT ID NCT07349433

Symptom relief Sponsor: Tang-Du Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new, custom-made 3D-printed device to hold breathing tubes in place for 66 obese adults. Standard methods often fail because of short necks and extra tissue, causing dangerous tube movement. The new holder is designed to fit each patient's face, and researchers compared it to usual methods to see if it improves stability, skin health, and comfort.

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

66 people

The number who actually took part.

Started

Jul 2024

Finished

May 2025

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 to 65 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: * Age 18-75 years. * Meets indications for endotracheal intubation. * Body Mass Index (BMI) ≥28 kg/m². * Intact skin around the mouth, cheeks, and neck without lesions before endotracheal intubation. * Estimated intubation time \>12 hours. * The patient or their family understands and voluntarily participates in this study, and signs the informed consent form. Exclusion Criteria: * Patients with a history of psychiatric diagnosis. * Patients with laryngeal injury. * Patients with oral diseases or facial skin damage. * Patients who have undergone intubation more than once during the current hospitalization.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Artificial airway management Obesity & overweight

Contacts and locations

Locations

  • Tangdu Hospital

    Xi'an, Shaanxi, 710038, China

More trials for these conditions

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