3D-Printed Artificial Airway Fixation Device for Obese Patients

NCT07349433 | Completed

• 1 other identifier: HLXJSXYW-2024-04
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Obesity &Amp; Overweight; Artificial Airway Management

Keywords

3D Printing; Personalized Fixation Device; Artificial Airway; Endotracheal Intubation; Obesity; Critical Care; Unplanned Extubation; Tube Displacement

Outcome Measures

Primary Outcomes (3)

• 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).

  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".

  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.

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

Study Arms (2)

3D-Printed Personalized Fixation Device

EXPERIMENTAL

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

Device: 3D-Printed Personalized Artificial Airway Fixation Device

Conventional Fixation Methods

ACTIVE COMPARATOR

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.

Other: Conventional Fixation Methods

Interventions

3D-Printed Personalized Artificial Airway Fixation Device 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.

3D-Printed Personalized Fixation Device

Conventional Fixation Methods 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.

Conventional Fixation Methods

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: January 16, 2026
• Study Start: July 9, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The de-identified individual participant data will be publicly shared within 6 months after the first publication of the main research results. The data will remain available for a minimum of 5 years.
• Access Criteria: Data will be made available for use by the scientific research community. Access will be provided through a data application and sharing mechanism via the ResMan platform. All shared data will be de-identified to protect participant privacy .

Locations

CN (1)