NCT07349433

3D-Printed Artificial Airway Fixation Device for Obese Patients

Study on 3D-Printed Artificial Airway Fixation Device for Obese Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Artificial Airway Management
• Obesity &Amp; Overweight

Interventions

Type	Name	Description
DEVICE	3D-Printed Personalized Artificial Airway Fixation Device	This study uses a personalized artificial airway fixation device for obese patients, developed with 3D printing technology, to secure the endotracheal tube.For Orotracheally Intubated Patients: A fixation device is personalized based on the patient's head and facial contour data. The device is integrally printed with medical-grade silicone-like soft and hard resin, featuring a soft skin-friendly inner side, a rigid movable dual-track structural design, and antimicrobial material on the inner wall.
OTHER	Conventional Fixation Methods	For Orotracheally Intubated Patients: The standard method involves passing the endotracheal tube through a conventional fixer, tightening the screw cap, and fastening a strap around the neck.

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-05-16
• Completion: 2025-05-16
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China