Tracheostomy decannulation leaves an iatrogenic passage in the upper airways. Inadequate sealing leads to pulmonary dysfunction and reduced voice quality. This study aimed to investigate the feasibility and impact of intratracheal tracheostomy sealing on laryngeal airflow and voice quality immediately after decannulation (ClinicalTrials.gov: NCT06138093). Fifteen adult, tracheostomized, intensive care unit patients were included from our hospital. A temporary, silicone-based sealing disc was inserted in the tracheostomy wound immediately after decannulation. Spirometry with measurement of forced vital capacity (FVC), forced expiratory volume in the first second (FEV₁), and peak expiratory flow (PEF) were performed as measures of airway flow. Voice recordings were assessed using an equal appearing interval scale from 1 to 5. Median FVC, FEV₁, PEF, and voice quality score with interquartile range (IQR) was 883 (510–1910) vs. 1260 (1005–1723) mL (p < 0.001), 790 (465–1255) vs. 870 (617–1297) mL (p < 0.001), 103 (55–211) vs. 107 (62–173) mL (p = 0.720), and 2 (1–2.5) vs. 4 (3–5) points (p < 0.001), respectively, with open tracheostomy vs. after sealing the tracheostomy with the intratracheal sealing disc. This feasibility study showed that tracheostomy sealing with the intratracheal disc was safe and led to immediate improvements in FVC, FEV₁, and voice quality.

After decannulation, air leak through the tracheostoma can impair cough and voice. We evaluated a second-generation temporary intratracheal sealing disc that seals the stoma from within. Two preclinical sub-studies were performed: Sub-study 1 cadaveric deployment to assess anatomical fit, seal integrity, and removability; and Sub-study 2, a 7-day porcine implantation with anatomical compatibility and blinded histology. In cadavers, the sealing disc maintained airway patency and sealed the stoma, withstanding peak intratracheal pressures up to 180 cmH ₂ O; removal through a near-healed opening required approximately 5 N traction. In the porcine model, no airway obstruction or clinical distress was observed, and histology (Phase Two) showed no excess inflammation or foreign body reaction versus sham. The sealing disc provided intraluminal sealing of the tracheostomy with feasible insertion and removal characteristics and a favorable short-term tissue response in preclinical models. These findings support clinical feasibility testing of this approach to maintain an intact airway dynamic during early post-decannulation healing.

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.