Clinical application of disposable tracheostomy cannulae

OBJECTIVE: To investigate the clinical application value of a novel disposable cuffless tracheostomy cannula during the decannulation transition period in high-risk patients, and to evaluate its efficacy and safety in maintaining airway patency, reducing decannulation-related risks, and improving patient outcomes. METHODS: This study was a prospective observational study enrolling 35 patients with high-risk airways admitted between June 2023 and April 2025. All patients had a history of tracheostomy and had been weaned from mechanical ventilation. According to clinical conditions, the disposable cuffless tracheostomy cannula was inserted as a transitional airway support after removal of T-tubes, tracheal stents, metal cannulas, or endotracheal tubes. Routine capping observation was performed for 48-72 h postoperatively, and the device was removed after tolerance assessment. The primary outcome was decannulation success rate; secondary outcomes included the incidence of airway events requiring reintervention at 30 days, 90 days, and during long-term follow-up after decannulation. RESULTS: Among the 35 patients, the pre-insertion statuses were as follows: T-tube placement in 10 cases, metal cannula in 21 cases, endotracheal tube in 2 cases, and spontaneous breathing via nose and mouth in 2 cases. The disposable cannula was successfully removed with complete weaning from the artificial airway in 32 patients, yielding a decannulation success rate of 91.4%. Three patients developed dyspnea within 72 h after removal of the disposable cannula and were defined as decannulation failure, caused by upper tracheal stenosis and hypoxemia due to sputum obstruction. Among the 32 successfully decannulated patients, the median follow-up duration was 9 months. During follow-up, 8 patients (25%) developed recurrent airway stenosis requiring reintervention, with a median onset time of 16 days (range: 1-75 days) after decannulation; the remaining 24 patients maintained airway patency without further intervention. CONCLUSION: The disposable cuffless tracheostomy cannula demonstrates high clinical value during the decannulation transition period in high-risk patients. It provides a safe transitional window for unstable airway conditions after decannulation, effectively identifying patients at risk of acute decompensation and avoiding severe airway events caused by direct decannulation. The device is easy to operate, minimally invasive, and preserves phonation function, making it suitable for high-risk populations with tracheal stenosis, repeated intubation history, and removal of airway supports. Further validation of its application value and scope in larger samples and multidisciplinary populations is warranted.