Not_yet_recruitingNCT07198425

Predicting Success of Decannulation Using Wearable-derived Physiology : A Prospective Cohort Study

Sponsor: Bin Zhang

Trial Details

ConditionTracheostomy Decannulation, Physiological Parameter
InterventionSuccessful decannulation group; Failed decannulation group
StatusNot_yet_recruiting
Participants120
Est. Completion20 Nov 2026
Last Updated28 May 2026

Primary Outcome

Difference in physiological parameters between patients in the decannulation success and decannulation failure groups

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 18 years ≤ Age ≤ 90 years, non-mechanically ventilated patients. * Tracheotomy completed, ≥48 hours since cannula placement (postoperative early edema has stabilized). * Patient or legal representative has provided informed consent. Exclusion Criteria: * Recent (≤48 hours) major neck/upper airway surgery requiring avoidance of upper airway airflow impact. * Severe consciousness disorder/delirium (RASS ≤ -3 or ≥ +2), extreme anxiety/inability to cooperate. * Total laryngectomy or laryngo-tracheal separation. * Oral endotracheal intubation. * Age \<18 years, Age \> 90years. * Malignant tumor with an expected survival time ≤ 6 months. * Patients or legal representatives unable to obtain informed consent. * Known contraindications for tracheotomy decannulation. * Unable to comply with the use of wearable devices

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