- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00771186
Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study
Study Overview
Status
Conditions
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 performed in a serial fashion will allow some projection as to the timing of RLN recovery
Inclusion criteria:
- 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 criteria
- 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
Data to be recorded:
- Age of patient
- Gender
- Age of initial fiberoptic evaluation and of initial diagnosis
- Diagnosis
- Serial Laryngeal Recordings
- Fiberoptic Evaluations
LEMG Recording
While in a light plane of anesthesia, the following recordings will be routinely performed:
- 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 50 V
- 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 200 V
- 10 seconds of right vocal fold LEMG recorded with a gain of 50 V
- 10 seconds of right vocal fold LEMG recorded with a gain of 200 V
- 10 seconds of left vocal fold LEMG recorded with a gain of 50 V
- 10 seconds of left vocal fold LEMG recorded with a gain of 200 V
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
children with vocal fold immobility
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
return of vocal fold function
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher J Hartnick, MD, Massachusetts Eye and Ear Infirmary
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 07-12-078x
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vocal Fold Immobility
-
Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVocal Fold NodulesUnited States
-
Massachusetts Eye and Ear InfirmaryCompletedVocal Fold DevelopmentUnited States
-
University of California, Los AngelesNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruitingMid-membranous Vocal Fold Lesion
-
Tel-Aviv Sourasky Medical CenterRecruitingVocal Fold Polyp | Vocal Cord Cyst | Vocal Nodules in AdultsIsrael
-
Guangzhou First People's HospitalCompleted
-
University of PittsburghCompleted
-
Kringle Pharma, Inc.Recruiting
-
University College, LondonRecruitingNeurological Disorder | Ultrasound | Vocal Fold MovementUnited Kingdom
-
Shane A. ShapiroRecruitingVocal Fold ScarsUnited States
-
Karolinska University HospitalKarolinska Institutet; The Swedish Research Council; LaryngfondenCompletedImproved Healing of Scarred Vocal Folds | Improved Vocal Fold Status | Improved Vocal Fold FunctionSweden