Status:

NOT_YET_RECRUITING

Predicting Success of Decannulation Using Wearable-derived Physiology

Lead Sponsor:

Bin Zhang

Collaborating Sponsors:

Beijing Rehabilitation Hospital

Chinese PLA General Hospital

Conditions:

Tracheostomy Decannulation

Physiological Parameter

Eligibility:

All Genders

18-90 years

Brief Summary

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once...

Eligibility Criteria

Inclusion

  • Age ≥18 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.
  • Known contraindications for tracheotomy decannulation.

Exclusion

  • 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.
  • Malignant tumor with an expected survival time ≤ 6 months.
  • Patients or legal representatives unable to obtain informed consent.

Key Trial Info

Start Date :

September 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT07198425

Start Date

September 20 2025

End Date

October 1 2026

Last Update

September 30 2025

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