TracheostomyNCT07701226
Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients
A study testing Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device and Routine Tracheostomy Care and Conventional Fixation in people with Tracheostomy and Oral Cancer, run by Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Oral Cancer, Post-Tracheostomy Care
- What is being tested?
- Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device and Routine Tracheostomy Care and Conventional Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2025to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Patients with oral cancer who underwent tracheostomy or required a tracheostomy tube during hospitalization.
- Patients who were conscious and had normal comprehension and communication ability.
- Patients with intact cervical skin without skin damage, skin disease, or infection.
- Patients who voluntarily agreed to participate and provided written informed consent.
Who cannot join
- Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy.
- Pregnant women.
- Minors under 18 years of age.
- Patients with psychiatric disorders.
- Patients who were unable to cooperate with the study procedures or outcome assessments as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Effect of a Novel Tracheostomy Tube Fixation Device on Nursing Efficiency, Complication Rates, and Patient Comfort in Post-Tracheostomy Patients: A Randomized Controlled Trial
This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. The novel fixation device was designed to provide stable tube fixation, protect the cervical skin, facilitate wound care, and improve patient comfort.
A total of 150 eligible patients who underwent tracheostomy were randomly assigned to a treatment group or a control group. Patients in the control group received routine tracheostomy care and conventional fixation. Patients in the treatment group received the novel self-adhesive bidirectional tracheostomy tube fixation device in addition to routine tracheostomy care.
The study assessed whether the novel fixation device could reduce tracheostomy-related complications, improve nursing efficiency, reduce the frequency and duration of wound care, improve neck comfort, and maintain safe tracheostomy tube fixation.
Read the detailed description
Tracheostomy is commonly performed in patients who require airway management after oral and maxillofacial head and neck tumor surgery. Stable fixation of the tracheostomy tube and appropriate wound care are important for maintaining airway safety, reducing local complications, and improving patient comfort. Conventional fixation methods, such as gauze ties or routine fixation straps, may become contaminated by blood or secretions, may cause friction or pressure on the cervical skin, and may require frequent replacement. These issues can increase nursing workload and may contribute to local skin injury, infection, tube displacement, or patient discomfort.
This randomized controlled trial was designed to evaluate the clinical application value and efficacy of a novel self-adhesive bidirectional tracheostomy tube fixation device. The device is intended to provide stable tracheostomy tube fixation while facilitating wound observation, dressing replacement, and daily nursing care.
Eligible patients were post-tracheostomy patients with oral cancer who were conscious, had adequate comprehension and communication ability, had intact cervical skin without infection or skin disease, and provided informed consent. Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy, pregnant women, minors, and patients with psychiatric disorders were excluded.
Participants were randomly assigned to two groups. The control group received routine tracheostomy care, including conventional tube fixation, nebulization therapy as prescribed, sputum suctioning as needed, regular inner cannula cleaning, and routine sterile gauze dressing care. The treatment group received routine tracheostomy care plus the novel self-adhesive bidirectional tracheostomy tube fixation device. The device was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device.
The primary outcome was the occurrence of infection or inflammatory signs around the tracheostomy wound, including redness, swelling, heat, and pain. Secondary outcomes included the frequency of device or dressing replacement, duration of each wound care procedure, new cervical skin injury, tracheostomy tube displacement, and patient-reported neck comfort. Safety assessments included changes in oxygen saturation before and after use and the recording of adverse events, including tube dislodgement.
The purpose of this study was to determine whether the novel tracheostomy tube fixation device could improve nursing efficiency, reduce tracheostomy-related complications, and improve patient comfort compared with conventional fixation and routine tracheostomy care.
- Being tested
- Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device, Routine Tracheostomy Care and Conventional Fixation
- Keywords
- Novel Tracheostomy Tube Fixation Device, Tracheostomy Tube Fixation, Tracheostomy Care, Airway Rehabilitation, Nursing Efficiency, Complication Rate, Patient Comfort, Tracheostomy Wound Care, Cervical Skin Injury, Tube Displacement, Oral Cancer Patients, Randomized Controlled Trial
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation DeviceDevice
The novel self-adhesive bidirectional tracheostomy tube fixation device was used for tracheostomy tube fixation in addition to routine tracheostomy care. After drying the wound area, the device was placed between the patient and the tracheostomy tube, with the posterior side attached to the cervical skin. The anterior hook-and-loop components were passed through the fixation wings of the tracheostomy tube and adjusted to secure the tube. The device was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device.
Routine Tracheostomy Care and Conventional FixationOther
Routine tracheostomy care included conventional tracheostomy tube fixation, nebulization therapy as prescribed, sputum suctioning as needed, regular cleaning or replacement of the inner cannula, and sterile gauze dressing care. Conventional fixation was performed using gauze ties or routine fixation straps around the neck with appropriate tightness. The tracheostomy wound dressing was changed twice daily or earlier if blood or exudate soaked two-thirds of the gauze dressing.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in the treatment group received routine tracheostomy care plus a novel self-adhesive bidirectional tracheostomy tube fixation device. The device was applied for tracheostomy tube fixation and was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device. Receives: Device: Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device; Other: Routine Tracheostomy Care and Conventional Fixation |
| Control Group | Active comparator | Participants in the control group received routine tracheostomy care and conventional tracheostomy tube fixation. Routine care included nebulization therapy as prescribed, sputum suctioning as needed, regular cleaning or replacement of the inner cannula, and sterile gauze dressing care. Receives: Other: Routine Tracheostomy Care and Conventional Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Tracheostomy Wound Infection
The occurrence of infection or inflammatory signs around the tracheostomy wound was assessed, including redness, swelling, heat, and pain around the tracheostomy site.
Measured: From intervention initiation to hospital discharge, up to 14 days
Secondary outcomes (5)
Frequency of Dressing or Device Replacement
The number of dressing or fixation device replacements was recorded. Replacement was performed once daily or earlier if blood or exudate soaked two-thirds of the dressing or device.
Measured: From intervention initiation to hospital discharge, up to 14 days
Duration of Each Dressing or Device Replacement Procedure
The time required for each dressing or fixation device replacement procedure was recorded. Timing started when the dressing or device replacement began and ended after the fixation device or dressing was properly adjusted and secured.
Measured: From intervention initiation to hospital discharge, up to 14 days
Incidence of New Cervical Skin Injury
New cervical skin injury around the tracheostomy tube fixation area was recorded, including newly developed pressure injury, skin redness, skin breakdown, or other fixation-related skin damage.
Measured: From postoperative day 1 to hospital discharge, up to 14 days
Incidence of Tracheostomy Tube Displacement
Tracheostomy tube displacement was assessed by marking the skin incision site as 0 cm. Tube movement of 0.8 cm or less was considered displacement according to the study protocol.
Measured: From intervention initiation to hospital discharge, up to 14 days
Patient-Reported Neck Comfort Score
Patient-reported neck comfort was assessed using a 0-to-10 scale. Conscious patients were asked to describe their wearing experience, with scores of 0 to 2 indicating comfort and scores of 3 to 10 indicating discomfort.
Measured: From intervention initiation to hospital discharge, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start7 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- 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
- Model description
- This is a two-arm, parallel, randomized controlled trial. Eligible post-tracheostomy patients were randomly assigned to either the treatment group or the control group. The control group received routine tracheostomy care and conventional fixation, while the treatment group received routine tracheostomy care plus a novel self-adhesive bidirectional tracheostomy tube fixation device.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuting Xie, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701226
- Sponsor's protocol ID
- SH9H-TRACH-FIX-2025
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the main study results will be shared after removal of personal identifiers. Shared data may include baseline characteristics, intervention records, outcome measures, and adverse event data. No names, hospital identification numbers, contact information, or other personally identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Tracheostomy Tube Fixation Device on Nursing Efficiency, Complication Rates, and Patient Comfort in Post-Tracheostomy Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07701226
- Acronym / sponsor ID
- SH9H-TRACH-FIX-2025
- Keywords
- Novel Tracheostomy Tube Fixation Device, Tracheostomy Tube Fixation, Tracheostomy Care, Airway Rehabilitation, Nursing Efficiency, Complication Rate, Patient Comfort, Tracheostomy Wound Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 14 Jul 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 evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. The novel fixation device was designed to provide stable tube fixation, protect the cervical skin, facilitate wound care, and improve patient comfort.
A total of 150 eligible patients who underwent tracheostomy were randomly assigned to a treatment group or a control group. Patients in the control group received routine tracheostomy care and conventional fixation. Patients in the treatment group received the novel self-adhesive bidirectional tracheostomy tube fixation device in addition to routine tracheostomy care.
The study assessed whether the novel fixation device could reduce tracheostomy-related complications, improve nursing efficiency, reduce the frequency and duration of wound care, improve neck comfort, and maintain safe tracheostomy tube fixation.
Detailed description
Tracheostomy is commonly performed in patients who require airway management after oral and maxillofacial head and neck tumor surgery. Stable fixation of the tracheostomy tube and appropriate wound care are important for maintaining airway safety, reducing local complications, and improving patient comfort. Conventional fixation methods, such as gauze ties or routine fixation straps, may become contaminated by blood or secretions, may cause friction or pressure on the cervical skin, and may require frequent replacement. These issues can increase nursing workload and may contribute to local skin injury, infection, tube displacement, or patient discomfort.
This randomized controlled trial was designed to evaluate the clinical application value and efficacy of a novel self-adhesive bidirectional tracheostomy tube fixation device. The device is intended to provide stable tracheostomy tube fixation while facilitating wound observation, dressing replacement, and daily nursing care.
Eligible patients were post-tracheostomy patients with oral cancer who were conscious, had adequate comprehension and communication ability, had intact cervical skin without infection or skin disease, and provided informed consent. Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy, pregnant women, minors, and patients with psychiatric disorders were excluded.
Participants were randomly assigned to two groups. The control group received routine tracheostomy care, including conventional tube fixation, nebulization therapy as prescribed, sputum suctioning as needed, regular inner cannula cleaning, and routine sterile gauze dressing care. The treatment group received routine tracheostomy care plus the novel self-adhesive bidirectional tracheostomy tube fixation device. The device was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device.
The primary outcome was the occurrence of infection or inflammatory signs around the tracheostomy wound, including redness, swelling, heat, and pain. Secondary outcomes included the frequency of device or dressing replacement, duration of each wound care procedure, new cervical skin injury, tracheostomy tube displacement, and patient-reported neck comfort. Safety assessments included changes in oxygen saturation before and after use and the recording of adverse events, including tube dislodgement.
The purpose of this study was to determine whether the novel tracheostomy tube fixation device could improve nursing efficiency, reduce tracheostomy-related complications, and improve patient comfort compared with conventional fixation and routine tracheostomy care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel, randomized controlled trial. Eligible post-tracheostomy patients were randomly assigned to either the treatment group or the control group. The control group received routine tracheostomy care and conventional fixation, while the treatment group received routine tracheostomy care plus a novel self-adhesive bidirectional tracheostomy tube fixation device.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device, Other: Routine Tracheostomy Care and Conventional FixationParticipants in the treatment group received routine tracheostomy care plus a novel self-adhesive bidirectional tracheostomy tube fixation device. The device was applied for tracheostomy tube fixation and was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device. |
| Control Group | Active comparator | Other: Routine Tracheostomy Care and Conventional FixationParticipants in the control group received routine tracheostomy care and conventional tracheostomy tube fixation. Routine care included nebulization therapy as prescribed, sputum suctioning as needed, regular cleaning or replacement of the inner cannula, and sterile gauze dressing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Patients with oral cancer who underwent tracheostomy or required a tracheostomy tube during hospitalization.
- Patients who were conscious and had normal comprehension and communication ability.
- Patients with intact cervical skin without skin damage, skin disease, or infection.
- Patients who voluntarily agreed to participate and provided written informed consent.
Key exclusion criteria (5 listed)
- Patients with pre-existing pressure injury, skin damage, allergy, or infection in the anterior cervical region before tracheostomy.
- Pregnant women.
- Minors under 18 years of age.
- Patients with psychiatric disorders.
- Patients who were unable to cooperate with the study procedures or outcome assessments as judged by the investigators.
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 |
|---|---|---|
| Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation DeviceThe novel self-adhesive bidirectional tracheostomy tube fixation device was used for tracheostomy tube fixation in addition to routine tracheostomy care. After drying the wound area, the device was placed between the patient and the tracheostomy tube, with the posterior side attached to the cervical skin. The anterior hook-and-loop components were passed through the fixation wings of the tracheostomy tube and adjusted to secure the tube. The device was replaced once daily, or earlier if blood or exudate soaked two-thirds of the device. | Device | Treatment Group |
| Routine Tracheostomy Care and Conventional FixationRoutine tracheostomy care included conventional tracheostomy tube fixation, nebulization therapy as prescribed, sputum suctioning as needed, regular cleaning or replacement of the inner cannula, and sterile gauze dressing care. Conventional fixation was performed using gauze ties or routine fixation straps around the neck with appropriate tightness. The tracheostomy wound dressing was changed twice daily or earlier if blood or exudate soaked two-thirds of the gauze dressing. | Other | Control Group, Treatment Group |
Primary outcome
Incidence of Tracheostomy Wound Infection
Time frame: From intervention initiation to hospital discharge, up to 14 days
The occurrence of infection or inflammatory signs around the tracheostomy wound was assessed, including redness, swelling, heat, and pain around the tracheostomy site.
5 secondary outcomes
Frequency of Dressing or Device Replacement
Time frame: From intervention initiation to hospital discharge, up to 14 days
Duration of Each Dressing or Device Replacement Procedure
Time frame: From intervention initiation to hospital discharge, up to 14 days
Incidence of New Cervical Skin Injury
Time frame: From postoperative day 1 to hospital discharge, up to 14 days
Incidence of Tracheostomy Tube Displacement
Time frame: From intervention initiation to hospital discharge, up to 14 days
Patient-Reported Neck Comfort Score
Time frame: From intervention initiation to hospital discharge, up to 14 days
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 14 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the main study results will be shared after removal of personal identifiers. Shared data may include baseline characteristics, intervention records, outcome measures, and adverse event data. No names, hospital identification numbers, contact information, or other personally identifiable information will be shared.
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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 Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device and Routine Tracheostomy Care and Conventional Fixation in people with Tracheostomy and Oral Cancer, run by Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 5 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 14 Jul 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?
Incidence of Tracheostomy Wound Infection (time frame: From intervention initiation to hospital discharge, up to 14 days). 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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.