Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients
Effect of a Novel Tracheostomy Tube Fixation Device on Nursing Efficiency, Complication Rates, and Patient Comfort in Post-Tracheostomy Patients: A Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedFirst Submitted
Initial submission to the registry
July 9, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedJuly 14, 2026
July 1, 2026
6 months
July 9, 2026
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From intervention initiation to hospital discharge, up to 14 days
Secondary Outcomes (5)
Frequency of Dressing or Device Replacement
From intervention initiation to hospital discharge, up to 14 days
Duration of Each Dressing or Device Replacement Procedure
From intervention initiation to hospital discharge, up to 14 days
Incidence of New Cervical Skin Injury
From postoperative day 1 to hospital discharge, up to 14 days
Incidence of Tracheostomy Tube Displacement
From intervention initiation to hospital discharge, up to 14 days
Patient-Reported Neck Comfort Score
From intervention initiation to hospital discharge, up to 14 days
Other Outcomes (2)
Change in Oxygen Saturation Before and After Device Use
Before and after device or dressing use during hospitalization, up to 14 days
Incidence of Adverse Events
From intervention initiation to hospital discharge, up to 14 days
Study Arms (2)
Treatment Group
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This was an open-label study because the tracheostomy tube fixation method was visible to both participants and care providers. No masking was implemented.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2026
First Posted
July 14, 2026
Study Start
May 7, 2025
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning November 1, 2026, and available for 5 years.
- Access Criteria
- Data will be available to qualified researchers for academic and non-commercial research purposes after submission of a reasonable request and approval by the principal investigator and the study institution. Requesters will be required to sign a data use agreement and comply with ethical and privacy protection requirements.
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.