Dynamic Laryngotracheal Separation for Aspiration - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

February 17, 2009

Start Date ^ICMJE

August 2004

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00580346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tolerance of implanted device [ Time Frame: immediate to several years ] [ Designated as safety issue: Yes ]
comfort in swallowing [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Dynamic Laryngotracheal Separation for Aspiration

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Data pending

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Aspiration Pneumonia

Intervention ^ICMJE

Device: Placement of laryngeal implant

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580346

Responsible Party

Michael Broniatowski, MD, University Hospitals of Cleveland health System

Study ID Numbers ^ICMJE

01-01-02, NIH DC-006703-01, IDE G980179

Study Sponsor ^ICMJE

University Hospitals of Cleveland

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael Broniatowski, MD

University Hospitals of Cleveland

Information Provided By

University Hospitals of Cleveland

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP