NCT07435727Recruiting
Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients
Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
This study aims to compare the efficacy and safety of the Speaking Valve trial versus the traditional Capping trial as indicators for tracheostomy decannulation in stroke patients. The trial is a prospective, multicenter, randomized, parallel-group, outcomes-assessor-blinded study with an exploratory crossover design.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 21 Feb 2026
- Start date
- 15 May 2026
- Primary completion date
- 15 May 2027
- Lead sponsor
- Hongying Jiang, MD
- Diseases
- Stroke
- NCT number
- NCT07435727
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 May 2026 to the primary completion date, 15 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe airway structural abnormalities: tracheal stenosis (\>50% lumen occlusion confirmed by Computed Tomography or bronchoscopy), tracheoesophageal fistula.
- Severe uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).
Other
- Intolerance to cuff deflation: severe cough, dyspnea, SpO₂ \<93% (on supplemental oxygen), or respiratory rate \>20/min for \>5 minutes.
- Life expectancy \<2 weeks or planned transfer to a non-participating institution within 2 weeks.
Who the study is looking for
- Stroke (ischemic or hemorrhagic) with subsequent tracheostomy. Stable stage of stroke: clinically in the post-acute or sequelae stage, with stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits.
- Clinically stable, defined as: ventilator-free for ≥48 hours prior to enrollment; stable vital signs (temperature \<38°C, heart rate 60-100 bpm, respiratory rate \<20/min, systolic blood pressure 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; partial pressure of Carbon Dioxide(PaCO₂) \<60 mmHg.
- Peak Cough Flow (PCF) ≥100 L/min. 24-hour subglottic secretion volume \<20 ml. Signed informed consent by patient or legal representative.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Rehabilitation Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.