Dynamic Laryngotracheal Separation for Aspiration
Primary Purpose
Aspiration Pneumonia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement of laryngeal implant
Sponsored by
About this trial
This is an interventional treatment trial for Aspiration Pneumonia focused on measuring Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
Eligibility 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
Sites / Locations
- University Hospitals Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2
Arm Description
Outcomes
Primary Outcome Measures
Videotaping vocal cords and modified barium swallows
Secondary Outcome Measures
Tolerance of implanted device
comfort in swallowing
Full Information
NCT ID
NCT00580346
First Posted
December 21, 2007
Last Updated
July 18, 2022
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00580346
Brief Title
Dynamic Laryngotracheal Separation for Aspiration
Official Title
Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia
Keywords
Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Placement of laryngeal implant
Other Intervention Name(s)
Modified Finetech Vocare Bladder stimulator, Huntington perineural electrodes
Intervention Description
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
Primary Outcome Measure Information:
Title
Videotaping vocal cords and modified barium swallows
Time Frame
several months
Secondary Outcome Measure Information:
Title
Tolerance of implanted device
Time Frame
immediate to several years
Title
comfort in swallowing
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Broniatowski, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Health System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11801992
Citation
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. doi: 10.1097/00005537-200111000-00031.
Results Reference
background
Learn more about this trial
Dynamic Laryngotracheal Separation for Aspiration
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