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Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients

NCT07701226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Tracheostomy
  • Oral Cancer
  • Post-Tracheostomy Care
  • Tracheostomy Complications

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701226 on ClinicalTrials.gov