Predicting Success of Decannulation Using Wearable-derived Physiology

NCT07198425 | Not Yet Recruiting DMC

• 1 other identifier: 2025-bjkfyy-ppfs-ud
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Tracheostomy Decannulation; Physiological Parameter

Keywords

speaking valve; Physiological Parameter; tracheostomy decannulation

Outcome Measures

Primary Outcomes (1)

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

  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: 1. Develop predictive models to assess the probability of successful decannulation prior to the procedure. 2. Investigate the relationship between time-series features (e.g., circadian rhythms, volatility) and decannulation outcomes. 3. 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.

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre-decannulation rehabilitation therapy for tracheotomy patients

You may qualify if:

• 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

Sponsors & Collaborators

• Bin Zhang: lead
• Beijing Rehabilitation Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Officials

• Hongying Jiang

  Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

  STUDY CHAIR

Central Study Contacts

Bin Zhang

CONTACT

+8618600530758; zbzgzjz@sina.com

Hongying Jiang

CONTACT

+8601056981555; 6jhy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 30, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share