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

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.

Stroke survivors may develop disorders of consciousness, dysphagia, and airway dysfunction, with some requiring tracheostomy for prolonged mechanical ventilation or airway protection. Prolonged tracheostomy tube placement can lead to complications such as infection, tracheal stenosis, and communication difficulties. Timely and safe decannulation is crucial for rehabilitation. While the capping trial (typically 48-72 hours) is widely used, the speaking valve offers potential advantages by restoring physiological airflow and facilitating communication. This trial will systematically compare these two methods to provide evidence for optimizing decannulation protocols.

Inclusion Criteria:

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 Criteria:

Intolerance to cuff deflation: severe cough, dyspnea, SpO₂ <93% (on supplemental oxygen), or respiratory rate >20/min for >5 minutes.

Severe airway structural abnormalities: tracheal stenosis (>50% lumen occlusion confirmed by Computed Tomography or bronchoscopy), tracheoesophageal fistula.

Life expectancy <2 weeks or planned transfer to a non-participating institution within 2 weeks.

Severe uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).