An interventional study of Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device and Routine Tracheostomy Care and Conventional Fixation in Tracheostomy, Oral Cancer and Post-Tracheostomy Care, sponsored by Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Supportive care
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.
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.
377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.
This study's enrollment of 150 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →This is the only study on the registry with Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device · Other: Routine Tracheostomy Care and Conventional Fixation
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.
Other: Routine Tracheostomy Care and Conventional Fixation
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.
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.
Time frame: From intervention initiation to hospital discharge, up to 14 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From intervention initiation to hospital discharge, up to 14 days
Change in Oxygen Saturation Before and After Device Use
Oxygen saturation was assessed before and after use of the tracheostomy tube fixation device or conventional fixation method to evaluate respiratory safety.
Time frame: Before and after device or dressing use during hospitalization, up to 14 days
Incidence of Adverse Events
Adverse events were recorded during the study period, including tracheostomy tube dislodgement and other device- or care-related adverse events. The time of occurrence, severity, duration, management, and outcome were documented.
Time frame: From intervention initiation to hospital discharge, up to 14 days
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.