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

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy; Oral Cancer; Tracheostomy Complications; Post-Tracheostomy Care
• Intervention / Treatment: Device: Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device; Other: Routine Tracheostomy Care and Conventional Fixation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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; 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.
Active Comparator: Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From intervention initiation to hospital discharge, up to 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From intervention initiation to hospital discharge, up to 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Patient Comfort; Complication Rate; Tube Displacement; Nursing Efficiency; Novel Tracheostomy Tube Fixation Device; Tracheostomy Tube Fixation; Tracheostomy Care; Airway Rehabilitation; Tracheostomy Wound Care; Cervical Skin Injury; Oral Cancer Patients
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Mouth Neoplasms
• Other Study ID Numbers: SH9H-TRACH-FIX-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning November 1, 2026, and available for 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No