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Dynamic Laryngotracheal Separation for Aspiration

This study has suspended participant recruitment.
(Protocol currently reviewed for updating)
Information provided by:
University Hospitals Cleveland Medical Center Identifier:
First received: December 21, 2007
Last updated: February 17, 2009
Last verified: January 2009
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.

Condition Intervention Phase
Aspiration Pneumonia Device: Placement of laryngeal implant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator

Resource links provided by NLM:

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Videotaping vocal cords and modified barium swallows [ Time Frame: several months ]

Secondary Outcome Measures:
  • Tolerance of implanted device [ Time Frame: immediate to several years ]
  • comfort in swallowing [ Time Frame: one year ]

Estimated Enrollment: 3
Study Start Date: August 2004
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Device: Placement of laryngeal implant
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
Other Names:
  • Modified Finetech Vocare Bladder stimulator
  • Huntington perineural electrodes

Detailed Description:
Data pending

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00580346

United States, Ohio
University Hospitals Health System
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Principal Investigator: Michael Broniatowski, MD University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Michael Broniatowski, MD, University Hospitals of Cleveland health System Identifier: NCT00580346     History of Changes
Other Study ID Numbers: 01-01-02
NIH DC-006703-01
IDE G980179
Study First Received: December 21, 2007
Last Updated: February 17, 2009

Keywords provided by University Hospitals Cleveland Medical Center:
Aspiration pneumonia
Implanted laryngeal stimulator
Vocal cord closure
Modified barium swallow

Additional relevant MeSH terms:
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on September 19, 2017