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NOT YET RECRUITING
NCT07435727
NA

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

Sponsor: Hongying Jiang, MD

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-04-01

Completion Date

2027-07-01

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

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, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.

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.

Locations (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Beijing Municipality, China