Status:
COMPLETED
Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Vocal Fold Immobility
Eligibility:
All Genders
Up to 18 years
Brief Summary
The goal of this study is to further study the role of LEMG in accurately predicting the recovery of vocal function as well to study the timing of a change of LEMG activity prior to such return of fun...
Detailed Description
Study design: Primary central hypothesis: Operative LEMG performed in a serial fashion can predict return of RLN function in children after iatrogenic injury. Secondary hypothesis: Operative LEMG ...
Eligibility Criteria
Inclusion
- Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
- Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
- Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so
Exclusion
- Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
- Children with congenital VFI where the etiology is not clearly identified
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00771186
Start Date
January 1 2008
End Date
December 1 2009
Last Update
June 22 2010
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114