Stroke PatientsSVBDP-TSPNCT07904169
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
An observational study of Stroke Patients and Tracheostomy, run by Hongying Jiang, MD.
Trial summary
To evaluate the feasibility of a speaking-valve-based decannulation protocol in tracheostomized stroke patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Patients, Tracheostomy
- What is being tested?
- Decannulation Protocol
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tracheostomized stroke patients in stable phase of stroke
Who may be able to join
- Tracheostomy performed following stroke (ischemic or hemorrhagic);
- Stable phase of stroke: clinically defined as the intermediate-to-late recovery phase plus the sequelae phase, during which the patient exhibits stable vital signs, resolution of cerebral edema, normalization of intracranial pressure, and absence of new neurological deficits (e.g., no recurrence of hemiplegia or aphasia), thereby entering a phase focused primarily on rehabilitation and secondary prevention.
- Written informed consent has been obtained and approved by the Institutional Review Board (IRB).
Who cannot join
- Expected survival time <2 weeks, or planned transfer to another non-cooperative healthcare facility within 2 weeks;
- Presence of severe, uncontrolled neurological disorders or other systemic diseases (e.g., advanced cancer, severe heart failure).
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: Application of a Speaking-Valve-Based Decannulation Protocol in Tracheostomized Stroke Patients: A Prospective Multicenter Cohort Study
To evaluate the feasibility of a speaking-valve-based decannulation protocol in tracheostomized stroke patients
Read the detailed description
Some patients with severe stroke require tracheostomy due to prolonged mechanical ventilation or airway protection. Prolonged use of a tracheostomy tube may lead to a range of complications-including infections, tracheal stenosis, and dysphagia or communication difficulties-which can adversely affect patient recovery and quality of life. Therefore, when patients' respiratory function improves and patients acquire the capability for airway protection, timely and safe removal of the tracheostomy tube constitutes a critical step in the rehabilitation process. The research of the investigators' center has demonstrated that a standardized tracheostomy tube removal protocol based on a speaking valve, implemented by the investigators' rehabilitation team, is associated with successful tube removal in patients with long-term tracheostomies. Accordingly, the investigators intend to evaluate the application of this standardized speaking-valve-based tracheostomy tube removal protocol in stroke patients with tracheostomies, aiming to assess its feasibility and safety in this patient population.
- Conditions
- Stroke Patients, Tracheostomy
- Being tested
- Decannulation Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decannulation ProtocolDiagnostic test
a Speaking-Valve-Based Decannulation Protocol
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomized Stroke Patients | Tracheostomized Stroke Patients Receives: Diagnostic Test: Decannulation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation success rate
(Decannulation - Decannulation failure) / Total number of errolled patients
Measured: From the date of enrollment to the date of 48 hours after extubation，assessed up to 9months
Secondary outcomes (2)
Time to decannulation
Days from clinically stable to decantation
Measured: From the date when patients in stable clinical conditions to the date of decannulation，assessed up to 3 months
Reintubation rate
Unplanned reiteration from 48 hours post decannulation to 90 days follow up
Measured: From 48 hours post decannulation to 90 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies 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
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Fengtai Rehabilitation Hospital of Beijing Municipal, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai, Zhengzhou Central Hospital
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, Study chair, Beijing Rehabilitation Hospital, Capital Medical University, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904169
- Sponsor's protocol ID
- 2026-bkhx-SVBDP-TSP
- Acronym
- SVBDP-TSP
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Speaking-Valve-Based Decannulation Protocol in Tracheostomized Stroke Patients: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07904169
- Acronym / sponsor ID
- SVBDP-TSP / 2026-bkhx-SVBDP-TSP
- Conditions
- Stroke Patients, Tracheostomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Fengtai Rehabilitation Hospital of Beijing Municipal, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai, Zhengzhou Central Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 29 Oct 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 evaluate the feasibility of a speaking-valve-based decannulation protocol in tracheostomized stroke patients
Detailed description
Some patients with severe stroke require tracheostomy due to prolonged mechanical ventilation or airway protection. Prolonged use of a tracheostomy tube may lead to a range of complications-including infections, tracheal stenosis, and dysphagia or communication difficulties-which can adversely affect patient recovery and quality of life. Therefore, when patients' respiratory function improves and patients acquire the capability for airway protection, timely and safe removal of the tracheostomy tube constitutes a critical step in the rehabilitation process. The research of the investigators' center has demonstrated that a standardized tracheostomy tube removal protocol based on a speaking valve, implemented by the investigators' rehabilitation team, is associated with successful tube removal in patients with long-term tracheostomies. Accordingly, the investigators intend to evaluate the application of this standardized speaking-valve-based tracheostomy tube removal protocol in stroke patients with tracheostomies, aiming to assess its feasibility and safety in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheostomized Stroke Patients | – | Diagnostic Test: Decannulation ProtocolTracheostomized Stroke Patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tracheostomized stroke patients in stable phase of stroke
Key inclusion criteria (3 listed)
- Tracheostomy performed following stroke (ischemic or hemorrhagic);
- Stable phase of stroke: clinically defined as the intermediate-to-late recovery phase plus the sequelae phase, during which the patient exhibits stable vital signs, resolution of cerebral edema, normalization of intracranial pressure, and absence of new neurological deficits (e.g., no recurrence of hemiplegia or aphasia), thereby entering a phase focused primarily on rehabilitation and secondary prevention.
- Written informed consent has been obtained and approved by the Institutional Review Board (IRB).
Key exclusion criteria (2 listed)
- Expected survival time <2 weeks, or planned transfer to another non-cooperative healthcare facility within 2 weeks;
- Presence of severe, uncontrolled neurological disorders or other systemic diseases (e.g., advanced cancer, severe heart failure).
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 |
|---|---|---|
| Decannulation Protocola Speaking-Valve-Based Decannulation Protocol | Diagnostic test | Tracheostomized Stroke Patients |
Primary outcome
Decannulation success rate
Time frame: From the date of enrollment to the date of 48 hours after extubation，assessed up to 9months
(Decannulation - Decannulation failure) / Total number of errolled patients
2 secondary outcomes
Time to decannulation
Time frame: From the date when patients in stable clinical conditions to the date of decannulation，assessed up to 3 months
Reintubation rate
Time frame: From 48 hours post decannulation to 90 days follow up
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 29 Oct 2026.
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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, Capital Medical University, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Patients and Tracheostomy, run by Hongying Jiang, MD.
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 2 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 29 Oct 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 Qian Feng (010-56981098, fengqian0263@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decannulation success rate (time frame: From the date of enrollment to the date of 48 hours after extubation，assessed up to 9months). 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 29 Oct 2026.