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.
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
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:
- 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.
- Conditions
- Vocal Fold Immobility
- Keywords
- pediatric, Laryngeal EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with vocal fold immobility | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted13 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal Fold ImmobilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Investigators
- Christopher J Hartnick, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT00771186
- Acronym / sponsor ID
- 07-12-078x
- Conditions
- Vocal Fold Immobility
- Keywords
- pediatric, Laryngeal EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with vocal fold immobility | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with vocal fold immobility
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
return of vocal fold function
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 22183907Maturo 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.
Related trials for Vocal Fold Immobility
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Hartnick, MD principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
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.