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Completed

NCT Number: NCT07349433

3D-Printed Artificial Airway Fixation Device for Obese Patients

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.

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Key information

Conditions

Artificial Airway Management Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity &Amp; Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Endotracheal Tube Displacement or Dislodgement Grade

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

    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).

  2. Local Skin Integrity

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

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

  3. Airway Management Safety Indicators

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

    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.

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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