Artificial Airway ManagementNCT07349433
3D-Printed Artificial Airway Fixation Device for Obese Patients
A study testing 3D-Printed Personalized Artificial Airway Fixation Device and Conventional Fixation Methods in people with Artificial Airway Management and Obesity &Amp; Overweight, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Artificial Airway Management, Obesity &Amp; Overweight
- What is being tested?
- 3D-Printed Personalized Artificial Airway Fixation Device and Conventional Fixation Methods
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2024to 16 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- 3D-Printed Personalized Artificial Airway Fixation Device, Conventional Fixation Methods
- Keywords
- 3D Printing, Personalized Fixation Device, Artificial Airway, Endotracheal Intubation, Obesity, Critical Care, Unplanned Extubation, Tube Displacement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Fixation Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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".
Measured: 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.
Measured: Average of measurements taken during each oral care procedure from intubation through extubation (an average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start9 Jul 2024
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Airway ManagementStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349433
- Sponsor's protocol ID
- HLXJSXYW-2024-04
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data collected during the study will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on 3D-Printed Artificial Airway Fixation Device for Obese Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349433
- Acronym / sponsor ID
- HLXJSXYW-2024-04
- Keywords
- 3D Printing, Personalized Fixation Device, Artificial Airway, Endotracheal Intubation, Obesity, Critical Care, Unplanned Extubation, Tube Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Personalized Fixation Device | Experimental | Device: 3D-Printed Personalized Artificial Airway Fixation DeviceThis arm uses a personalized artificial airway fixation device for obese patients, developed with 3D printing technology, to secure the endotracheal tube. |
| Conventional Fixation Methods | Active comparator | Other: Conventional Fixation MethodsFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Personalized Artificial Airway Fixation DeviceThis 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. | Device | 3D-Printed Personalized Fixation Device |
| Conventional Fixation MethodsFor 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 |
Primary outcome
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).
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".
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data collected during the study will be shared.
Related trials for Artificial Airway Management
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Personalized Artificial Airway Fixation Device and Conventional Fixation Methods in people with Artificial Airway Management and Obesity &Amp; Overweight, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal Tube Displacement or Dislodgement Grade (time frame: From intubation through extubation, an average of 7 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.