Dynamic Laryngotracheal Separation for Aspiration

Aspiration Pneumonia Clinical Trial

Official title:

Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580346
• Other study ID #: 01-01-02
• Secondary ID: NIH DC-006703-01
• Status: Withdrawn
• Phase: N/A
• Start date: August 2004
• Est. completion date: July 2009

Study information

• Verified date: July 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Data pending

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• Placement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both

Locations

Country	Name	City	State
United States	University Hospitals Health System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Videotaping vocal cords and modified barium swallows		several months
Secondary	Tolerance of implanted device		immediate to several years
Secondary	comfort in swallowing		one year