Intratracheal Seal Disc: A Novel Tracheostoma Closure Device

Christiansen, Karen Juelsgaard; Moeslund, Niels; Lauridsen, Henrik; Devantier, Louise; Rohde, Marianne Cathrine; Kjærgaard, Benedict; Pedersen, Michael

doi:10.4187/respcare.05301

Cited by 1 publication

(2 citation statements)

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“…The subjects were hospitalized in the ICU for a mean of 10 days before being tracheostomized, most often using a percutaneous dilatational tracheostomy, and they were decannulated after a median of 15 days following tracheostomy. Median duration of stay at ICU (IQR) was 24 (19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) days.…”

Section: Patient Characteristicsmentioning

confidence: 99%

“…Recently, we presented a new concept that enables intratracheal sealing of the tracheostomy wound after decannulation by means of a sealing silicone disc placed on the luminal side of the trachea [25,26]. The hypothesis of our study is that sealing of the tracheostomy immediately after decannulation by insertion of the sealing disc re-establishes physiological airflow and improves the patient's ability to speak compared with current standard care, leaving the tracheostomy wound open.…”

Section: Introductionmentioning

confidence: 99%

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Novel Method for Sealing Tracheostomies Immediately after Decannulation—An Acute Clinical Feasibility Study

Kraghede,

Christiansen,

Kaspersen

et al. 2024

Biomedicines

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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.

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