The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping. Physiological monitoring was performed for each enrolled patient on the day before their first use of the speaking valve, with continuous monitoring lasting 24 hours. Differences in the 24-hour physiological parameters with clinical parameters on the day before speaking valve use between the successful decannulation group and the failed decannulation group were compared. Decannulation criteria: If the patient can tolerate wearing the speaking valve continuously for 4 hours (gradually increasing the duration: 30 minutes, 1 hour, 2 hours, 4 hours), and if PEF \> 100 liters/min, planned removal of the tracheostomy tube can be considered. Based on decannulation outcomes, patients were categorized into the successful decannulation group and the failed decannulation group. Successful decannulation group: Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulation. Failed decannulation group: Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.
Study Type
OBSERVATIONAL
Enrollment
120
Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulbation.
Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.
Difference in physiological parameters between patients in the decannulation success and decannulation failure groups
Primary endpoint: Whether "decannulation success" (binary: success/failure) is achieved within 48 hours after the first planned removal of the tracheostomy tube in tracheostomized patients. Primary Objectives: Comparing key physiological parameters between the successful and failed tracheostomy decannulation groups to identify objective indicators associated with successful decannulation. Secondary Objectives: 1. Develop predictive models to assess the probability of successful decannulation prior to the procedure. 2. Investigate the relationship between time-series features (e.g., circadian rhythms, volatility) and decannulation outcomes. 3. Identify potentially modifiable physiological risk signals (e.g., nocturnal hypoxic burden, reduced heart rate variability). Wearable device data collection time: Within 24 hours after the patient enters the decannulation process and before the first use of a speaking valve.
Time frame: During the 24 hours before wearing the speaking valve on the day of entering the decannulation process
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