3D-Printed Artificial Airway Fixation Device for Obese Patients

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

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 Overview

• Status: Completed
• Conditions: Obesity &Amp; Overweight; Artificial Airway Management
• Intervention / Treatment: Device: 3D-Printed Personalized Artificial Airway Fixation Device; Other: Conventional Fixation Methods

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): May 16, 2025
• Study Completion (Actual): May 16, 2025

Study Registration Dates

• First Submitted: September 12, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; 3D Printing; Critical Care; Endotracheal Intubation; Personalized Fixation Device; Artificial Airway; Unplanned Extubation; Tube Displacement
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HLXJSXYW-2024-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified individual participant data collected during the study will be shared.
• IPD Sharing 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.
• IPD Sharing 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 .
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No