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NCT Number: NCT07198425

Predicting Success of Decannulation Using Wearable-derived Physiology

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.

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Key information

Conditions

Tracheostomy Decannulation Physiological Parameter

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Successful decannulation group

Other

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.

Failed decannulation group

Other

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.

Primary outcomes

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

Time frame: Monitor for 24 hours on the day of patient admission. During the 24 hours before wearing the speaking valve on the day of entering the decannulation process
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: Compare the differences in physiological parameters between the successful and failed decannulation groups, and integrate their respective clinical indicators to identify objective markers associated with successful extubation.

Secondary Objectives:
- Develop predictive models to assess the probability of successful decannulation prior to the procedure.
- Investigate the relationship between time-series features (e.g., circadian rhythms, volatility) and decannulation outcomes.
- Identify potentially modifiable physiological risk signals (e.g., nocturnal hypoxic burden, reduced heart rate variability).
Wearable device data collection time: Monitoring for 24 hours after patient admission and prior to the initial use of the speaking valve.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Zhang

CONTACT

[email protected]

+8618600530758

Hongying Jiang

CONTACT

[email protected]

+8601056981555

Sponsors and collaborators

Lead sponsor

Bin Zhang

Other

Collaborators

Beijing Rehabilitation Hospital of Capital Medical University
Chinese PLA General Hospital

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Sep 30, 2025
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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