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

Biomedicines. 2024 Apr 12;12(4):852. doi: 10.3390/biomedicines12040852.

Abstract

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.

Keywords: clinical study; critical care; mechanical ventilators; rehabilitation; respiratory function tests; respiratory insufficiency; tracheostomy.

Associated data

  • ClinicalTrials.gov/NCT06138093