Tracheostomy DecannulationEffect of SVNCT07422350
The Effect of Speaking Valve on Physiological Parameters With Wearable Devices
An observational study of Tracheostomy Decannulation, run by Jingyi Ge at 1 site in China.
Trial summary
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheostomy Decannulation
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 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: Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation
Who may be able to join
- Patient is not receiving mechanical ventilation.
- Tolerates cuff deflation.
- Upper airway patency is good, TTP < 10 cmH2O.
- Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
- PaCO2<60 mmHg.
Who cannot join
- Cannot tolerate deflation balloon.
- Severe upper airway obstruction
- Unstable vital signs.
- Thick secretions, compromised airway protection.
- PaCO2 ≥60 mmHg.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
Hong ying Jiang, +8601056981555, 6jhy@163.com
About this study
Official title: The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Read the detailed description
A speaking valve (such as the common one-way valve/Passy-Muir type) is a one-way device attached to the external opening of a tracheostomy tube: the valve opens during inhalation, allowing air to flow in through the tracheostomy tube; it closes during exhalation, directing airflow upwards through the glottis and out through the mouth and nose, thereby restoring upper airway exhalation, vibrating the vocal cords to produce sound, and enhancing functions such as swallowing, smell, taste, and secretion clearance. This study aims to gather physiological parameter data using non-invasive wearable devices during speaking valve use, compare the differences between before and after wearing speaking valve.It also compares key physiological parameters between the group that can tolerate the speaking valve and the group that cannot. Identify objective indicators associated with successful tolerance.
- Conditions
- Tracheostomy Decannulation
- Keywords
- difficult decannulation, tracheostomized patients, Wearable devices, speaking valves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tolerance Cohort | Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ < 60 mmHg). | |
| Intolerance Cohort | Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of differences in key physiological parameters between two patient groups
Primary endpoint: Whether the tracheostomy patient's first use of a speaking valve is successful,duration of use 30 minutes.Primary Objectives:Data from 120 patients were collected using wearable devices,including respiratory rate(RR),heart rate(HR),fingertip blood oxygen saturation(SaO₂),respiratory movement amplitude(RMA),etc.RR and HR refer to the average respiratory and heart rates per minute during monitoring,respectively(breaths/min,beats/min).SaO₂ represents the average oxygen saturation recorded during monitoring(%).RMA means the average thoracic respiratory movement amplitude during monitoring(mm).This study aims to identify factors that can predict successful tolerance of the speaking valve, enhance the decannulation process focused on the "speaking valve," and increase the the success rate of decannulation.
Measured: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).
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 start31 Jan 2026 (estimated)
- Primary completion20 Oct 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
- Jingyi Ge
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Peking University Cancer Hospital & Institute, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Jingyi Ge, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422350
- Sponsor's protocol ID
- 2025-bjkfyy-twdmp-svt
- Acronym
- Effect of SV
- Status last verified
- Jan 2026
- First submitted
- 7 Sep 2025
- Last updated
- 20 Feb 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices
- ClinicalTrials.gov ID
- NCT07422350
- Acronym / sponsor ID
- Effect of SV / 2025-bjkfyy-twdmp-svt
- Conditions
- Tracheostomy Decannulation
- Keywords
- difficult decannulation, tracheostomized patients, Wearable devices, speaking valves
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jingyi GeUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Peking University Cancer Hospital & Institute, Chinese PLA General Hospital
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (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.
To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.
Detailed description
A speaking valve (such as the common one-way valve/Passy-Muir type) is a one-way device attached to the external opening of a tracheostomy tube: the valve opens during inhalation, allowing air to flow in through the tracheostomy tube; it closes during exhalation, directing airflow upwards through the glottis and out through the mouth and nose, thereby restoring upper airway exhalation, vibrating the vocal cords to produce sound, and enhancing functions such as swallowing, smell, taste, and secretion clearance. This study aims to gather physiological parameter data using non-invasive wearable devices during speaking valve use, compare the differences between before and after wearing speaking valve.It also compares key physiological parameters between the group that can tolerate the speaking valve and the group that cannot. Identify objective indicators associated with successful tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolerance Cohort | – | –Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ < 60 mmHg). |
| Intolerance Cohort | – | –Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation
Key inclusion criteria (5 listed)
- Patient is not receiving mechanical ventilation.
- Tolerates cuff deflation.
- Upper airway patency is good, TTP < 10 cmH2O.
- Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
- PaCO2<60 mmHg.
Key exclusion criteria (5 listed)
- Cannot tolerate deflation balloon.
- Severe upper airway obstruction
- Unstable vital signs.
- Thick secretions, compromised airway protection.
- PaCO2 ≥60 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of differences in key physiological parameters between two patient groups
Time frame: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).
Primary endpoint: Whether the tracheostomy patient's first use of a speaking valve is successful,duration of use 30 minutes.Primary Objectives:Data from 120 patients were collected using wearable devices,including respiratory rate(RR),heart rate(HR),fingertip blood oxygen saturation(SaO₂),respiratory movement amplitude(RMA),etc.RR and HR refer to the average respiratory and heart rates per minute during monitoring,respectively(breaths/min,beats/min).SaO₂ represents the average oxygen saturation recorded during monitoring(%).RMA means the average thoracic respiratory movement amplitude during monitoring(mm).This study aims to identify factors that can predict successful tolerance of the speaking valve, enhance the decannulation process focused on the "speaking valve," and increase the the success rate of decannulation.
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 20 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Decannulation, run by Jingyi Ge at 1 site in China.
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 5 inclusion and 5 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison of differences in key physiological parameters between two patient groups (time frame: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).). 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 20 Feb 2026.