Clinical feasibility of intratracheal tracheostomy sealing using a novel sealing disc prototype

After tracheostomy decannulation, stoma openings compromise airway integrity, reduce subglottic pressure, and impair cough efficiency. Conventional external dressings are often not airtight and require extensive maintenance, increasing the risk of delayed healing and pulmonary complications. We evaluated the feasibility, physiological impact, and patient-reported outcomes of an intratracheal sealing disc designed to maintain airway integrity during early post-decannulation healing. In this feasibility study, 21 tracheostomized patients were enrolled from the Department of Intensive Care at Aarhus University Hospital and Gødstrup Regional Hospital (pilot phase, n = 11; main study, n = 10). Immediately after decannulation, a sealing disc was inserted intratracheally and secured externally for up to 7 days. Spirometry, voice quality, and tracheostomy healing were assessed daily. Patient satisfaction was measured using a questionnaire with a 5-point Likert scale. The sealing disc provided an airtight closure during speaking and coughing. Placement and removal were quick and uneventful. Patient satisfaction overall reached a median (interquartile range) score of 5/5 (1). Forced vital capacity, forced expiratory volume in the first second, and voice quality improved significantly immediately after sealing and remained stable during wear and after removal. In this First-in-Man clinical feasibility study, intratracheal sealing immediately after decannulation proved feasible, well-tolerated, and may improve pulmonary function, phonation, and wound healing. Larger controlled studies are warranted.Trial Registration: This trial was retrospectively registered at ClinicalTrials.gov with the identifier NCT07149116 - date of registration: 08/08/2025.