Predicting Success of Decannulation Using Wearable-derived Physiology

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Conditions studied: Tracheostomy Decannulation, Physiological Parameter

In brief

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. Each enrolled patient received physiological monitoring upon admission and the day prior to the initial use of the speaking valve, with continuous monitoring for 24 hours through wearable devices.The monitored physiological parameters were compared between the successful decannulation group and the failed decannulation group, and a predictive decannulation model was established in advance based on clinical parameters. 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.

Key facts

Study ID: NCT07198425
Run by: Bin Zhang
People needed: 120
Starts: 2026-06-02
Expected to finish: 2026-12-31
Last updated by the study team: 2026-05-28

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Full record on ClinicalTrials.gov

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