Dynamic Laryngotracheal Separation for Aspiration
Not Applicable
Withdrawn
- Conditions
- Aspiration Pneumonia
- Interventions
- Device: Placement of laryngeal implant
- Registration Number
- NCT00580346
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- 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 Description
Data pending
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Aspiration pneumonia after neurological insults (e.g. stroke)
- Ability to understand the purpose of the research
- Appropriate hand motor control
- Inability to improve under standard treatments (speech-language pathologists)
- Acceptance of a tracheostomy
Exclusion Criteria
- Lack of understanding the research
- Poor hand motor coordination
- Uncontrolled seizures
- Pregnancy
- Refusal to accept a tracheostomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 Placement of laryngeal implant -
- Primary Outcome Measures
Name Time Method Videotaping vocal cords and modified barium swallows several months
- Secondary Outcome Measures
Name Time Method comfort in swallowing one year Tolerance of implanted device immediate to several years
Trial Locations
- Locations (1)
University Hospitals Health System
🇺🇸Cleveland, Ohio, United States