3D-Printed Artificial Airway Fixation Device for Obese Patients

NCT ID: NCT07349433

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2025-05-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

3D-Printed Personalized Fixation Device

This arm uses a personalized artificial airway fixation device for obese patients, developed with 3D printing technology, to secure the endotracheal tube.

Group Type: EXPERIMENTAL

3D-Printed Personalized Artificial Airway Fixation Device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional Fixation Methods

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tangdu Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

HLXJSXYW-2024-04

Identifier Type: -

Identifier Source: org_study_id