Clinical Trial: Dynamic Laryngotracheal Separation for Aspiration
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
Brief Summary: People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.
Detailed Summary: Data pending
Sponsor: University Hospitals Cleveland Medical Center
Current Primary Outcome: Videotaping vocal cords and modified barium swallows [ Time Frame: several months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tolerance of implanted device [ Time Frame: immediate to several years ]
- comfort in swallowing [ Time Frame: one year ]
Original Secondary Outcome: Tolerance of implanted device [ Time Frame: immediate to several years ]
Information By: University Hospitals Cleveland Medical Center
Dates:
Date Received: December 21, 2007
Date Started: August 2004
Date Completion: July 2009
Last Updated: February 17, 2009
Last Verified: January 2009
