Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Successful decannulation group.
- Who it may be relevant to
- Registry conditions: Physiological Parameters, Wearable Devices, Tracheostomy Decannulation. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices) [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07424196 · 2026bkky-048