Tracheostomy DecannulationNCT07198425
Predicting Success of Decannulation Using Wearable-derived Physiology
An observational study of Tracheostomy Decannulation and Physiological Parameter, run by Bin Zhang.
Trial summary
The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheostomy Decannulation, Physiological Parameter
- What is being tested?
- Successful decannulation group and Failed decannulation group
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-decannulation rehabilitation therapy for tracheotomy patients
Who may be able to join
- 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.
Who cannot join
- 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.
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- Patients or legal representatives unable to obtain informed consent.
- Known contraindications for tracheotomy decannulation.
- Unable to comply with the use of wearable devices
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predicting Success of Decannulation Using Wearable-derived Physiology : A Prospective Cohort Study
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.
Read more
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.
- Being tested
- Successful decannulation group, Failed decannulation group
- Keywords
- speaking valve, Physiological Parameter, tracheostomy decannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successful decannulation groupOther
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 groupOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start2 Jun 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy DecannulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Bin Zhang, Capital Medical University
- Investigators
- Hongying Jiang, Study chair, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198425
- Sponsor's protocol ID
- 2026bkky-052
- Status last verified
- May 2026
- First submitted
- 14 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Success of Decannulation Using Wearable-derived Physiology : A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07198425
- Acronym / sponsor ID
- 2026bkky-052
- Keywords
- speaking valve, Physiological Parameter, tracheostomy decannulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bin ZhangUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Chinese PLA General Hospital
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-decannulation rehabilitation therapy for tracheotomy patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Successful decannulation groupPatients 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. | Other | – |
| Failed decannulation groupPatients 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. | Other | – |
Primary outcome
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: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongying Jiang study chair
Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Decannulation and Physiological Parameter, run by Bin Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Zhang (+8618600530758, zbzgzjz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.