CompletedNot Applicable

3D-Printed Artificial Airway Fixation Device for Obese Patients

China66 participantsStarted 2024-07-09

Plain-language summary

This study is looking for a better way to secure breathing tubes for obese patients who need them. For patients with obesity, a short neck and extra tissue can make it difficult to keep a breathing tube in the correct position. When a tube moves, it can cause serious problems. Researchers want to compare a new, personalized breathing tube holder with the standard methods currently used. Participants in this study will be randomly assigned to one of two groups: The Intervention Group will use a new tube holder made with a 3D printer. This holder is custom-designed to fit the specific shape of the patient's face. The Control Group will use the standard methods to secure the breathing tube, such as a conventional holder or medical tape. Researchers will check things like how well the tube stays in place, the condition of the patient's skin around the mouth, and the comfort of the patient. The goal is to see if the new 3D-printed device is safer, more secure, and more comfortable for obese patients with a breathing tube. The study will include 66 adult patients who are obese and require a breathing tube.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endotracheal Tube Displacement or Dislodgement Grade

Timeframe: From intubation through extubation, an average of 7 days.

Local Skin Integrity

Timeframe: Daily from intubation through extubation, up to 14 days.

Airway Management Safety Indicators

Timeframe: Average of measurements taken during each oral care procedure from intubation through extubation (an average of 7 days)

Trial details

NCT IDNCT07349433

SponsorTang-Du Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-16

View on ClinicalTrials.gov More Artificial Airway Management trials