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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Withdrawn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
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 21, 2007
Last Updated
July 18, 2022
Sponsor
University Hospitals Cleveland Medical Center
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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Withdrawn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.
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Dynamic Laryngotracheal Separation for Aspiration

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