Predicting Success of Decannulation Using Wearable-derived Physiology

Bin Zhang

Status: Not yet enrolling

Conditions: Physiological Parameter; Tracheostomy Decannulation

Treatments: Other: Successful decannulation group

Study type: Observational

Funder types: Other

Identifiers

NCT07198425

2025-bjkfyy-ppfs-ud

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.