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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tangdu Hospital
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.