Dynamic Laryngotracheal Separation for Aspiration - Full Text View

Purpose

People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examins 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
Neurological Insults Producing Aspiration Pneumonia	Device: Modified Vocare Stimulator, and Huntington perineural electrodes	Phase I

MedlinePlus related topics:

Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Double Blind (Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Videotaping vocal cords and modified barium swallows [ Time Frame: several months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerance of implanted device [ Time Frame: immediate to several years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3
Study Start Date:	August 2004
Estimated Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Device: Modified Vocare Stimulator, and Huntington perineural electrodes Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580346

Contacts


Contact: Michael Broniatowski, MD	216 363 2556	mbron@prodigy.net

Locations


United States, Ohio
	University Hospitals health System	Recruiting
	Cleveland, Ohio, United States, 44106
	Contact: Michael Broniatowski, MD 216-363-2556 mbron@prodigy.net

Sponsors and Collaborators

University Hospitals of Cleveland

More Information

Publications:

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.

Responsible Party:	University Hospitals of Cleveland health System ( Michael Broniatowski, MD )
Study ID Numbers:	01-01-02, NIH DC-006703-01, IDE G980179
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00580346
Health Authority:	United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:

Aspiration pneumonia

Implanted laryngeal stimulator

Vocal cord closure

Modified barium swallow

Study placed in the following topic categories:

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Pneumonia, Aspiration

Pneumonia

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00580346