Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study

NCT00771186 | Completed

• 1 other identifier: 07-12-078x
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vocal Fold Immobility

Keywords

pediatric; Laryngeal EMG

Outcome Measures

Primary Outcomes (1)

• return of vocal fold function

  one year

Study Arms (1)

children with vocal fold immobility

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with vocal fold immobility

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Maturo SC, Braun N, Brown DJ, Chong PS, Kerschner JE, Hartnick CJ. Intraoperative laryngeal electromyography in children with vocal fold immobility: results of a multicenter longitudinal study. Arch Otolaryngol Head Neck Surg. 2011 Dec;137(12):1251-7. doi: 10.1001/archoto.2011.184.

  PMID: 22183907 DERIVED

Study Officials

• Christopher J Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

US (1)