Predicting Success of Decannulation Using Wearable-derived Physiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tracheostomy Decannulation Physiological Parameter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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 decannulbation.

Intervention Type OTHER

Successful 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No