TracheostomyNCT07107243
SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients
A study testing Speaking valve combined with airway pressure and Bronchoscopy in people with Tracheostomy, run by Capital Medical University at 5 sites in China.
Trial summary
The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Speaking valve combined with airway pressure and Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2025to 31 Oct 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weaned from ventilator more than 48 hours
- No any organ failure
- No sepsis
- Stable heart rate and blood pressure
- Lung infection under control
- PCO2<60mmHg
- Patient and family sign informed consent form
Who cannot join
- Serious dysfunction of vital organs
- Inability to tolerate cuff deflation
- Laryngopharyngeal trauma
- Known severe upper airway obstruction before referrer to our department
- Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Rehabilitation Hospital of Capital Medical University
Beijing, Shijingshan, 100144
jingyi Ge, +861056981067, ge_jingyi2020@163.com
- Recruiting
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Jiangbin, 530012
Li Zheng, 86-17776263283, 819237886@qq.com
- Recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Henan, Zhengzhou, 450007
Yajing Wang, 86-15515645380, wangya568@163.com
- Recruiting
Hunan Rehabilitation Hospital
Hunan, Hunan, 410000
Pan Li, 86-18674765825, 584703769@qq.com
- Recruiting
YanBian University Hospital
Jilin City, Yanbian, 133000
Shenglan Jin, +864332660078, Shenglan91@163.com
About this study
Official title: Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study
The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.
- Conditions
- Tracheostomy
- Being tested
- Speaking valve combined with airway pressure, Bronchoscopy
- Keywords
- transtracheal end-expiratory pressure, speaking valve, upper airway, prolonged tracheostomized patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speaking valve combined with airway pressureDiagnostic test
All patients wore speaking valves for 30 minutes, during which the transtracheal end-expiratory pressure was measured to assess the patency of the upper airway.
BronchoscopyDiagnostic test
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
| Study group | Role | What they receive |
|---|---|---|
| True positive group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive. Receives: Diagnostic Test: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy |
| False positive group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative. Receives: Diagnostic Test: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy |
| True negative group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative. Receives: Diagnostic Test: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy |
| False negative group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive. Receives: Diagnostic Test: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency
Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated.
Measured: The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All patients received the speaking valve combined with the transtracheal end-expiratory pressure measurement protocol and bronchoscopy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, MD, Study chair, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107243
- Sponsor's protocol ID
- 2025-hxkfzx-dzx-001
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT07107243
- Acronym / sponsor ID
- 2025-hxkfzx-dzx-001
- Conditions
- Tracheostomy
- Keywords
- transtracheal end-expiratory pressure, speaking valve, upper airway, prolonged tracheostomized patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Aug 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 aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- All patients received the speaking valve combined with the transtracheal end-expiratory pressure measurement protocol and bronchoscopy.
| Arm | Type | Receives |
|---|---|---|
| True positive group | Experimental | Diagnostic Test: Speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive. |
| False positive group | Experimental | Diagnostic Test: Speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative. |
| True negative group | Experimental | Diagnostic Test: Speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative. |
| False negative group | Experimental | Diagnostic Test: Speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Weaned from ventilator more than 48 hours
- No any organ failure
- No sepsis
- Stable heart rate and blood pressure
- Lung infection under control
Key exclusion criteria (5 listed)
- Serious dysfunction of vital organs
- Inability to tolerate cuff deflation
- Laryngopharyngeal trauma
- Known severe upper airway obstruction before referrer to our department
- Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known
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 |
|---|---|---|
| Speaking valve combined with airway pressureAll patients wore speaking valves for 30 minutes, during which the transtracheal end-expiratory pressure was measured to assess the patency of the upper airway. | Diagnostic test | False negative group, False positive group, True negative group, True positive group |
| BronchoscopyThe same examiner performed bronchoscopy on all patients to assess upper airway patency. | Diagnostic test | False negative group, False positive group, True negative group, True positive group |
Primary outcome
The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency
Time frame: The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.
Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated.
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 21 Jan 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, MD study chair
Beijing Rehabilitation Hospital of Capital Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speaking valve combined with airway pressure and Bronchoscopy in people with Tracheostomy, run by Capital Medical University at 5 sites 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 7 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Hongying Jiang, MD (+8656981555, 6jhy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency (time frame: The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.). 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 21 Jan 2026.