Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Post-Tracheostomy Care | — | UNRESOLVED | — |
| Tracheostomy | — | UNRESOLVED | — |
| Tracheostomy Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device | Device | — | UNRESOLVED |
| Routine Tracheostomy Care and Conventional Fixation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- 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.
- interventionNames
- Device: Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device
- Other: Routine Tracheostomy Care and Conventional Fixation
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Other: Routine Tracheostomy Care and Conventional Fixation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available