Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction

Cincinnati Children's Hospital Medical Center

Status: Terminated

Conditions: Voice Disorders

Treatments: Procedure: Microlaryngoscopy; Procedure: Voice Evaluation; Procedure: Airway Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03076931

2016-2378

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 2 patients

Sex: All

Ages: 3 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Study: Airway Reconstruction Patients

Experimental group

Description:

These participants have significant airway abnormalities that require invasive surgery, such as Laryngotracheoplasty, to rectify, and whose voice quality may suffer as a result of the surgery. The goal of this study is to improve voice outcomes of these patients, and their clinical data will be collected.

Treatment:

Procedure: Voice Evaluation

Procedure: Microlaryngoscopy

Procedure: Airway Reconstruction

Control: Normal Airway Patients

Experimental group

Description:

These participants have normal airways and voice who will undergo a microlaryngoscopy and voice evaluation, the data from which will be compared to study patients.

Treatment:

Procedure: Voice Evaluation

Procedure: Microlaryngoscopy