3D-Printed Artificial Airway Fixation Device for Obese Patients

Tang-Du Hospital66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Artificial Airway Management Obesity &Amp; Overweight

Interventions

3D-Printed Personalized Artificial Airway Fixation DeviceDEVICE

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 MethodsOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Endotracheal Tube Displacement or Dislodgement Grade

The stability of the endotracheal tube is assessed using a 5-point grading scale. Grade 1: No displacement. Grade 2: Mild displacement (change of \<1 cm). Grade 3: Moderate displacement (change of 1-2 cm). Grade 4: Severe displacement (change of \>2 cm). Grade 5: Unplanned extubation (tube is completely dislodged).

Time frame: From intubation through extubation, an average of 7 days.

Local Skin Integrity

The contact area was inspected daily and recorded for skin irritation or allergic reaction, categorized as "Yes" or "No".

Time frame: Daily from intubation through extubation, up to 14 days.

Airway Management Safety Indicators

Safety indicators are measured during each nursing procedure (oral care and replacement of the fixation device), including: ①Irritative Cough Duration: The duration (in seconds) of a patient's continuous coughing or choking is recorded. ②Heart Rate and SpO₂ Fluctuation: Heart rate (beats/minute) and peripheral oxygen saturation (SpO₂) are monitored and recorded before and after each procedure to assess changes.

Time frame: Average of measurements taken during each oral care procedure from intubation through extubation (an average of 7 days)