Dynamic Laryngotracheal Separation for Aspiration

University Hospitals (UH)

Status: Withdrawn

Conditions: Aspiration Pneumonia

Treatments: Device: Placement of laryngeal implant

Study type: Interventional

Funder types: Other

Identifiers

NCT00580346

NIH DC-006703-01

IDE G980179

01-01-02

Details and patient eligibility

About

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.

Full description

Data pending

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 1 patient group

2

Experimental group

Treatment:

Device: Placement of laryngeal implant