Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices) (RVTR1)

Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. After the patient is admitted, the research team evaluates whether they are suitable to enter the decannulation process. For enrolled patients, a 24-hour wearable device is worn upon admission to record physiological parameters.

Patients, following clinical and rehabilitation treatment, can start using a "speaking valve" as soon as their condition permits. Within the first 24 hours prior to the initial use of the speaking valve, wearable devices may be utilized a second time to gather data.

Patients successfully completed the decannulation process, tolerating the speaking valve for 4 hours (PEF/PCF ≥ 100liters/min).The wearable device was utilized to gather 24 hours physiological parameters for the third time within the 24 hours leading up to decannulation.

Patients who underwent successful decannulation had physiological parameters collected for the forth time using wearable devices within 24 hours prior to discharge.

This study preliminarily compares the differences in physiological parameters at four time points (within 24 hours of admission, within 24 hours prior to using a speaking valve, within 24 hours prior to decannulation and within 24 hours before discharge), predicts the physiological benefits of decannulation for patients, and advocates for the concept of "early decannulation." 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/PCF ≥ 100 liters/min, planned removal of the tracheostomy tube can be considered.

Criteria for successful decannulation: 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wearable Devices; Tracheostomy Decannulation; Physiological Parameters
• Intervention / Treatment: Other: Successful decannulation group

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Hongying Jiang; Phone Number: +8601056981555; Email: 6jhy@163.com
• Study Contact Backup: Name: Bin Zhang; Phone Number: +8618600530758; Email: zbzgzjz@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent clinical and rehabilitation treatment both before and after decannulation.

Description

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.
• Following our department's 2018 decannulation procedure, patients who successfully completed decannulation

Exclusion Criteria:

• Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
• Interruption of physiological monitoring data;
• Poor quality of physiological monitoring data;
• 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.
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)	All patients enrolled in this study had their tracheostomy cannula successfully removed during hospitalization, and no tracheostomy cannula or orotracheal intubation was reinserted within 48 hours following decannulation.Primary Objectives: The clinical benefits of decannulation were further validated by observing the changes in patients' physiological parameters before and after the procedure.In clinical practice, we actively advocate for decannulation management through "early assessment, prompt decannulation, early advantage" to minimize unnecessary indwelling.	within 24 hours of admission, within 24 hours prior to using a speaking valve, within 24 hours prior to decannulation and within 24 hours before discharge.

Collaborators and Investigators

• Sponsor: Bin Zhang
• Collaborators: Chinese PLA General Hospital; Beijing Rehabilitation Hospital
• Investigators: Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physiological Parameters; Wearable Devices; speaking valve; Tracheostomy decannulation
• Other Study ID Numbers: 2026bkky-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No