Study of Speaking Valve Effects on Breathing, Swallowing, and Voice in Adults with Tracheostomy and Brain Injury

What this Trial Is About

Researchers are studying how a speaking valve affects breathing, swallowing, and vocal functions in patients who have a tracheostomy and disturbances of consciousness. The study focuses on participants who do not require mechanical ventilation and are in a state such as unresponsive wakefulness syndrome or minimally conscious state. This research aims to understand if using the speaking valve during respiratory therapy offers benefits in managing breathing and secretions. Participants are randomly assigned to one of two groups one group receives respiratory physical therapy treatments using the Shiley2 phonate speaking valve connected to their tracheostomy tube for at least 8 sessions over 2 weeks. The other group receives similar respiratory physical therapy without the speaking valve. The study compares these approaches to evaluate differences in breathing and vocal function. During the study, researchers measure changes in oxygen saturation and breathing rate over 15 minutes as primary outcomes. Secondary outcomes include swallowing rate, vocalization presence after 2 weeks, cough rate, and the percentage of patients weaned from the tracheostomy over approximately 6 months. The study involves ongoing assessments to monitor these outcomes and the participants respiratory function throughout the treatment period and follow-up.

Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.