Intratracheal Tracheostomy Sealing - A Clinical Feasibility Study

NCT07149116 | Completed

• 1 other identifier: 1-10-72-112-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate a new treatment method for tracheostomies - the term for the opening you have in your neck. The treatment method seals the stoma tract from within the trachea. The aim is to improve lung function and voice quality, as well as to promote wound healing. Study procedure: A silicone sealing device will be inserted into the stoma tract. This may cause temporary discomfort around the site and may induce some coughing. You will then undergo a pulmonary function test - also known as a spirometry test. For the following 7 days, the sealing device will remain in the stoma tract and provide an airtight seal. You will be examined daily with spirometry, and the healing of the stoma tract will be closely monitored. A member of the research team will be present with you around the clock to ensure that the device remains correctly positioned. This is a safety precaution in the unlikely event that the sealing device dislocates into the airway. After 7 days, the sealing device will be removed through the nearly healed stoma tract simply by pulling it out. This may again cause slight irritation or coughing.

Conditions

Tracheostomy Complications

Outcome Measures

Primary Outcomes (2)

• Feasibilty

  Ease of device insertion, intratracheal placement, and removal will be assessed by the operating clinician immediately after each procedure. The evaluation will be based on a structured qualitative rating (easy, moderate, difficult) informed by the operator's direct experience and the patient's oral feedback during the procedure.The unit of measure will be the number of procedures rated in each category.

  From inrollment to the end of treatment (maximum 7 days)

• Patient satisfaction (Questionnaire-Based Score)

  Patient satisfaction will be assessed using a structured questionnaire consisting of six items, each rated on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Scores from individual items will be summarized by reporting the median (IQR) for each item across patients. The unit of measure will be the patient-reported score (range 1-5).

  Filled out on the last day of dataretrieval (day 3-7)

Secondary Outcomes (5)

• Forced Vital Capacity (FVC) measured by spirometry

  From enrollment and until removal of the device (up to 7 days after enrollment)

• Forced Expiratory Volume in 1 Second (FEV₁) measured by spirometry

  From enrollment and until removal of the device (up to 7 days after enrollment)

• Peak Expiratory Flow (PEF) measured by spirometry

  From enrollment and until removal of the device (up to 7 days after enrollment)

• Voice quality score

  From enrollment and until removal of the device (up to 7 days after enrollment)

• Tracheostomy wound healing status (photographic evaluation)

  From enrollment and until removal of the device (up to 7 days after enrollment)

Study Arms (1)

Intratracheal sealing disc

EXPERIMENTAL

A silicone disc is inserted through the tracheostomy to seal it. The disc is removed through the remaining tracheostomy once the wound has healed around it.

Device: Tracheostomy sealing

Interventions

Tracheostomy sealing DEVICE

A non-classified silicone-based prototype device designed to temporarily seal the tracheostomy tract from within the airway for up to 7 days after decannulation.

Intratracheal sealing disc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tracheostomy in place for ≥7 days for the purpose of mechanical ventilation in ICU
• Age ≥18 years
• Uncuffed or occluded tracheostomy tube (size 7-8) during the last 24 hours

You may not qualify if:

• Cognitive impairment or incapacity to such a degree that the participant is unable to comprehend study information or cooperate with the required assessments

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 29, 2025
• Study Start: January 20, 2023
• Primary Completion: December 8, 2024
• Study Completion: March 8, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

DK (1)