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

Completed

• Conditions: Vocal Fold Development
• Interventions: Procedure: Children Examined with the OCT Probe

• Registration Number: NCT01810107
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

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.

Detailed Description

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 The optical imaging probe will then be withdrawn from the patient and the original operative procedure will then be performed.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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2019-09-26
• Study Completion: 2019-12-21
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children Examined with the OCT Probe	Children Examined with the OCT Probe	Children undergoing surgery will also have the Optical Coherence Tomography probe.
Adults	Children Examined with the OCT Probe	Adults undergoing surgery will also have the Optical Coherence Tomography probe.

Primary Outcome Measures

Name	Time	Method
Vocal Fold Development	30 seconds to a minute, in the operating room, before the otolaryngology procedure that they are originally there for. This time frame is all that is needed to image their vocal cords.	The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. The major analysis will be to validate the age dependent laminar structure using a cohort of 720 subjects between age 0-18 as well as estimate the probability of future events of developing two- or three laminar structure given a subject's age. We will perform one-sided two-sample binomial tests to examine as well as model the patterns of the rates of bi- and tri-laminar structure patterns by using logistic model or discrete or continuous time Cox's proportional hazards model of which the predictor variables are determined based on the discriminant model described above. In addition, as a parallel approach we will analyze the Optical Coherence Tomography (OCT) data of each of the trilaminar system by using linear or curve-linear regression models which will provide a prediction model of the mean OCT at various critical ages.

Trial Locations

Locations (1)

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States