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Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients
Sponsor: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-05-07
Completion Date
2025-10-31
Last Updated
2026-07-14
Healthy Volunteers
No
Interventions
Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device
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 Fixation
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.
Locations (1)
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China