Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction

Summary

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.

Conditions

• Voice Disorders

Interventions

PROCEDURE

Microlaryngoscopy

Standard clinical procedure, used to perform airway sizing and vocal fold calibration. Controls receive one as a research procedure, while study patients receive one as part of standard of care.

PROCEDURE

Voice Evaluation

Standard clinical procedure that includes aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and high-speed videoendoscopy. Controls will receive one as a research procedure, while study patients will receive three, one before their airway reconstruction, and two more in the year afterward, as part of standard of care.

PROCEDURE

Airway Reconstruction

This includes many types of invasive surgical procedures such as Laryngotracheoplasty to repair a patient's compromised airway. Only study patients will be receiving one, and it will be as part of standard of care unrelated to this study, but the data from surgery and outcomes being pertinent to the study.

Sponsors & Collaborators

• Triological Society

  collaborator UNKNOWN

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Alessandro de Alarcon, MD · CCHMC

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-01

Primary Completion

2019-10-15

Completion

2019-10-15

Countries

• United States

Study Locations