Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients

Official title

Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study

Overview

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.

Detailed description

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.

Interventions

• Other Passy-Muir Speaking Valve
  Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, peripheral capillary oxygen saturation(SpO₂) ≥93% (on room air or low-flow oxygen), no significant respiratory distress. If patients in the Capping Group group cannot tolerate continuous catheter occlusion for 48 hours, they are transferred to the Speaking Valve group and undergo a 4-hour voice valve test starting at 0.5 hours.
• Other Tracheostomy tube capping
  Gradual capping: 1hour → 48hours. Decannulation Criteria: Continuous tolerance for 48 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.

Primary outcome measures

• Decannulation Success Rate [Time frame: 48 hours post-decannulation]

Secondary outcome measures (4)

• Time to Decannulation [Time frame: From randomization to decannulation, assessed up to 30 days]
• Pneumonia Incidence at 30 Days [Time frame: 30 days post-decannulation]
• Reintubation Rate at 90 Days [Time frame: 90 days post-decannulation]
• Mortality Rate at 90 Days [Time frame: 90 days post-decannulation]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Rehabilitation Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07435727 · 2026-hx-SPEAK-CAP Stroke

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗