Physiological ParametersRVTR1NCT07424196
Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)
An observational study of Physiological Parameters and Wearable Devices, 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. After the patient is admitted, the research team evaluates whether they are suitable to enter the decannulation process. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Physiological Parameters, Wearable Devices, Tracheostomy Decannulation
- What is being tested?
- Successful decannulation group
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Mar 2027
- 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: Patients underwent clinical and rehabilitation treatment both before and after decannulation.
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.
- Following our department's 2018 decannulation procedure, patients who successfully completed decannulation
Who cannot join
- 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.
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- 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
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: 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.
Read more
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.
- Being tested
- Successful decannulation group
- Keywords
- speaking valve, Physiological Parameters, Wearable Devices, 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ParametersStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Rehabilitation 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
- NCT07424196
- Sponsor's protocol ID
- 2026bkky-048
- Acronym
- RVTR1
- Status last verified
- May 2026
- First submitted
- 14 Feb 2026
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation
- ClinicalTrials.gov ID
- NCT07424196
- Acronym / sponsor ID
- RVTR1 / 2026bkky-048
- Keywords
- speaking valve, Physiological Parameters, Wearable Devices, Tracheostomy decannulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bin ZhangUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Rehabilitation Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 20 Feb 2026 (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. 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 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
- Patients underwent clinical and rehabilitation treatment both before and after decannulation.
Key inclusion criteria (4 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.
- Following our department's 2018 decannulation procedure, patients who successfully completed decannulation
Key exclusion criteria (11 listed)
- 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.
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 | – |
Primary outcome
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.
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.
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 3 Jun 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 Physiological Parameters and Wearable Devices, 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 4 inclusion and 11 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 3 Jun 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?
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.). 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 3 Jun 2026.