Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
NCT Number: NCT00771186
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 function. We aim to do this by collaborating with several active pediatric otolaryngological practices throughout the country who in turn have agreed to evaluate infants and children with vocal fold immobility who fit a standardized inclusion and exclusion criteria by means of a standardized LEMG protocol over a one year period of time. Our particular goal is to collect and then review information over a one year period of time on all children evaluated for vocal fold immobility by means of LEMG.
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Notify MeUp to 18 year
All sexes
Observational
Boston, Massachusetts, 02114, United States
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 performed in a serial fashion will allow some projection as to the timing of RLN recovery
Inclusion criteria
Exclusion criteria
Data to be recorded:
LEMG Recording
While in a light plane of anesthesia, the following recordings will be routinely performed:
Total recording time: 60 seconds
Timing of LEMG and Awake Fiberoptic Laryngoscopy
Following current standard clinical evaluation we are performing at MEEI, we propose to perform awake fiberoptic laryngoscopy and operative LEMG at the following time points: initially (within 3 weeks of injury if possible), at the 3 month post-injury mark, and at the 9- month post injury mark ( 3 recordings in total; we will perform a final fiberoptic laryngoscopy in the office at the one year time interval). The time points were chosen as each recording necessitates an operative procedure with general anesthesia so we wanted to limit the over number of general anesthetics. We recognize that the risk of limiting the number of operative LEMG recordings is that we lose some data-points to chart recovery of RLN function, but we felt that the risks of multiple general anesthetics were sufficient enough to warrant limiting the number of recordings as much as possible.
Data Collection and Database protection
All Data collected will be entered into a password protected database.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one year
Massachusetts Eye and Ear Infirmary
Other
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