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Dynamic Laryngotracheal Separation for Aspiration

This study has suspended participant recruitment.
(Protocol currently reviewed for updating)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580346
First Posted: December 24, 2007
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580346


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

Publications:
Responsible Party: Michael Broniatowski, MD, University Hospitals of Cleveland health System
ClinicalTrials.gov Identifier: NCT00580346     History of Changes
Other Study ID Numbers: 01-01-02
NIH DC-006703-01
IDE G980179
First Submitted: December 21, 2007
First Posted: December 24, 2007
Last Update Posted: February 18, 2009
Last Verified: January 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
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections