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Vocal Fold ImmobilityNCT00771186

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

An observational study of Vocal Fold Immobility, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
Vocal Fold Immobility
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2008to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Children with vocal fold immobility

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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:

  1. Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
  2. Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
  3. Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so.

Exclusion criteria

  1. Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
  2. Children with congenital VFI where the etiology is not clearly identified

Data to be recorded:

  1. Age of patient
  2. Gender
  3. Age of initial fiberoptic evaluation and of initial diagnosis
  4. Diagnosis
  5. Serial Laryngeal Recordings
  6. Fiberoptic Evaluations

LEMG Recording

While in a light plane of anesthesia, the following recordings will be routinely performed:

  1. 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 50 V
  2. 10 seconds of both right and left vocal fold LEMG simultaneously recorded with a gain of 200 V
  3. 10 seconds of right vocal fold LEMG recorded with a gain of 50 V
  4. 10 seconds of right vocal fold LEMG recorded with a gain of 200 V
  5. 10 seconds of left vocal fold LEMG recorded with a gain of 50 V
  6. 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.

Keywords
pediatric, Laryngeal EMG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00771186
Study groupRoleWhat they receive
children with vocal fold immobilityNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. return of vocal fold function

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771186
Sponsor's protocol ID
07-12-078x
Status last verified
Jun 2010
First submitted
10 Oct 2008
Last updated
22 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22183907

Questions about this trial

What is this clinical trial studying?

An observational study of Vocal Fold Immobility, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

return of vocal fold function (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00771186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.

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