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

Launched by LOEWENSTEIN HOSPITAL · Jul 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a device called a speaking valve on patients with a tracheostomy, which is a surgical opening in the neck to help with breathing. The researchers believe that using this speaking valve may help improve breathing, swallowing, and vocal functions in certain patients who have difficulty responding due to brain injuries. The trial will involve participants who are awake but may not fully respond, and who do not require a breathing machine.

To be eligible for the trial, participants should be between the ages of 65 and 74, have a tracheostomy, and have a specific type of brain injury that affects their ability to respond. Additionally, their legal guardian must be able to speak Hebrew. Participants will take part in respiratory physical therapy sessions where the speaking valve will be used, and they can expect close monitoring and support throughout the trial. This study aims to understand better how this device can help improve patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • brain injury (traumatic/non-traumatic).
• • tracheostomy.
• • unresponsive wakefulness syndrome or minimally conscious state.
• • fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.
• • the legal guardian speaks Hebrew.
• Exclusion Criteria:
• • airway stenosis / inflammation.
• • oxygen saturation \<90%.