Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold



Status:Recruiting
Healthy:No
Age Range:Any - 99
Updated:3/8/2019
Start Date:July 2011
End Date:January 2020
Contact:Christopher Hartnick, MD
Email:christopher_hartnick@meei.harvard.edu
Phone:617-573-4206

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The specific aim of this study is to develop a growth and development chart (similar to a
height or weight chart for children) that identifies the pattern of development of the
pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim
is to identify whether this growth chart shows a pattern of linear development or whether
there are clear critical periods of development.

The goal of this study is to identify critical periods of development when the lamina propria
structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be
utilized for adequate laryngeal exposure. An operating microscope will be used for
magnification. This setup will allow for the Optical Coherence Tomography (OCT) imaging probe
to be introduced using a laryngoscope to provide stability. The optical imaging probe will
then be directed, or gently applied towards, the glottal surface, and an image field of 500
microns x 500 microns x 350 microns will be obtained. As the probe is moved along the medial
and superior mucosal surfaces of the vocal folds, "real-time" images will be obtained and
digitally stored for review. The digitally stored images will be assessed and analyzed for
their optical characteristics. The optical imaging probe will then be withdrawn from the
patient and the original operative procedure will then be performed. Images can be attained
in both "non-contact" mode (where the probe tip remains in the space between each vocal fold)
and "contact" mode (where the probe tip is gently placed against the glottal tissue to
compress it). The contact mode allows for deeper imaging (much like an ultrasound), which
would be useful in situations involving larger (thicker) vocal folds. The study will end when
images are acquired from a range of developmental ages to be able to refine the optical
characteristics of the optical imaging system.

Adults have also been included in this study for comparison as OCT imaging in adults may
confirm the number of vocal fold layers compared to children.

Inclusion Criteria:

- Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy
for airway evaluation where the patients will be already scheduled for general
anesthesia with intravenous catheter placement as part of standard routine.

- Children (and adults) undergoing any otolaryngology procedure where there is no
indication of airway obstruction or risk of abnormal vocal chords. For instance,
children undergoing adenoidectomy, sinus surgery or tracheotomy are all good
candidates for studying the normal vocal chord development.

- Children whose parents have given and signed an informed consent and Health Insurance
Portability and Accountability Act (HIPAA) Authorization and who have signed an assent
form (if they are 7 and older) agreeing to participate in the study. Eligibility will
be determined by the Principal Investigator.

- Adults who have given and signed an informed consent and HIPAA Authorization.

Exclusion Criteria:

- Children (or adults) with any form of laryngeal anomaly or pathology.

- Children who have previously been intubated.

- Children, adolescents, and adults who smoke. Exclusion will be determined by the
Principal Investigator.
We found this trial at
1
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Boston, Massachusetts 02115
Principal Investigator: Christopher Hartnick, MD
Phone: 617-573-4206
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Boston, MA
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