Two Ways to Test Readiness for Removing a Breathing Tube After Stroke
Compares a speaking valve and tube capping before tracheostomy removal in stroke patients.
Plain-language title generated from the registry record
Registry title: Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who had a stroke and then a tracheostomy, and who are now clinically stable.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Stroke (ischemic or hemorrhagic) followed by a tracheostomy, in the stable post-acute or sequelae stage: stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits.
- Earlier treatment
- Off the ventilator for at least 48 hours before enrollment.
- Biomarker or test result
- Peak Cough Flow of at least 100 L/min. 24-hour subglottic secretion volume under 20 ml. PaCO₂ under 60 mmHg.
Main reasons for not taking part
- Cannot tolerate cuff deflation: severe cough, breathlessness, SpO₂ below 93%, or breathing rate above 20/min for more than 5 minutes
- Tracheal stenosis of more than 50% or a tracheoesophageal fistula
- Life expectancy under 2 weeks, or planned transfer to a non-participating institution within 2 weeks
- Severe uncontrolled neurological or other body-wide disease, such as advanced cancer or severe heart failure
- Active severe infection needing IV antibiotics, or organ failure
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07435727, who can take part
Where in China
- Beijing Rehabilitation Hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hongying Jiang, MD
- Trial code
- NCT07435727
- Record updated
- 22 May 2026
- Original description
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.Read full original descriptionShow less
Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study
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.
Inclusion: 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.
Exclusion: 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); 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.