Aspiration Pneumonia
Conditions
Keywords
Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
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
Interventions
DEVICEPlacement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Videotaping vocal cords and modified barium swallows | several months |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance of implanted device | immediate to several years |
| comfort in swallowing | one year |
Countries
United States
Outcome results
None listed