3D-Printed Artificial Airway Fixation Device for Obese Patients

Tang-Du Hospital

Status: Completed

Conditions: Obesity &Amp; Overweight; Artificial Airway Management

Treatments: Other: Conventional Fixation Methods; Device: 3D-Printed Personalized Artificial Airway Fixation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07349433

HLXJSXYW-2024-04

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

3D-Printed Personalized Fixation Device

Experimental group

Description:

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

Treatment:

Device: 3D-Printed Personalized Artificial Airway Fixation Device

Conventional Fixation Methods

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Fixation Methods