Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction



Status:Recruiting
Healthy:No
Age Range:3 - 30
Updated:7/26/2018
Start Date:August 2016
Contact:Alessandro de Alarcon, MD
Email:alessandro.dealarcon@cchmc.org

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Objective:

The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an
imaging biomarker to support diagnosis and predict vibratory outcome after airway
reconstruction. Our protocol will involve eliciting and recording the following five
behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and
(5) sustained phonation. These HSV recordings will be used to develop the biomarkers.

Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway
reconstruction and 24 age matched controls.

Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati
Children's Hospital Medical Center

Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol,
at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery.
Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a
pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway
evaluation will include airway sizing and calibration.

Fifty percent of the children who undergo airway reconstruction for subglottic stenosis
(narrowing of the airway below the vocal folds) develop a voice disorder. Voice disorders
lead to psychosocial problems that affect many of these children over their lifetime,
specifically their career choices and their long-term quality of life. Our current
understanding of voice problems following surgical airway reconstruction is limited. There is
a lack of research to understand the alterations of the phonatory mechanisms due to the
underlying initial condition (stenosis) and the surgical airway reconstruction performed. The
purpose of this proposal is to develop and test imaging biomarkers to support diagnosis and
surgical decision-making leading to improved voice outcome. The overarching goal of this work
is to establish a foundation upon which surgical practice could be enhanced to improve voice
outcome while still achieving optimal airway results. Specifically, the project will use: a
prospective pre- and post-surgery cohort design to develop an imaging biomarker of "vibratory
potential" for predicting the vibratory outcome after airway reconstruction. Quantitative
image processing methodology will be used for the development and validation of the new
imaging biomarkers, based on high-speed videoendoscopy. This research project will address a
substantial gap of knowledge in pediatric voice and airway surgery, and has the potential to
significantly improve the quality of life of these patients who have some of the most severe
and difficult to manage voice disorders. The results could be translated to adult patient
populations and other voice disorders (e.g. development of disease-specific imaging
biomarkers).

Study Patients

Inclusion Criteria:

1. Ages of 3-30 years,

2. No prior airway surgery

3. Able to undergo the evaluation protocol

Exclusion Criteria:

1.) Patients who have undergone any prior airway reconstruction and/or have a disability
that precludes them from completing the evaluation

Control Patients

Inclusion Criteria:

1. Age of 3-30 years

2. No prior history of intubation injury or airway/laryngeal surgery

3. Normal hearing

4. Normal voice assessment performed by a certified speech-language pathologist 5.)
Undergoing a non-airway surgical procedure such as adenoidectomy, tonsillectomy, ear
tubes, and neck mass removal.

Exclusion Criteria:

1. Has had airway or laryngeal surgery

2. History of a voice or hearing disorder

3. History of neonatal intubation over 14 days

4. Have a disability that precludes them from completing the evaluation
We found this trial at
1
site
Cincinnati, Ohio 45229
Principal Investigator: Alessandro de Alarcon, MD
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Cincinnati, OH
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