NCT07349433Completed
3D-Printed Artificial Airway Fixation Device for Obese Patients
Study on 3D-Printed Artificial Airway Fixation Device for Obese Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 12 Sept 2025
- Start date
- 9 Jul 2024
- Primary completion date
- 16 May 2025
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Obesity
- NCT number
- NCT07349433
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 9 Jul 2024 to the primary completion date, 16 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a history of psychiatric diagnosis.
- Patients with oral diseases or facial skin damage.
Other
- Patients with laryngeal injury.
- Patients who have undergone intubation more than once during the current hospitalization.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.