Clinical trial NCT03076931: Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
Official title: Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Voice Disorders
Keywords: Voice
Biomarker
Airway Reconstruction
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Triological Society
First posted: 2017-03-10
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Identification of Patient's Vibratory Source
timeFrame: Up to One Year
Secondary outcomes:
measure: Tissue Health of Patient--Vocal Fold Vibration
timeFrame: Up to One Year
measure: Tissue Health of Patient--Scarring of Airway
timeFrame: Up to One Year
measure: Maximum Adduction
timeFrame: Up to One Year
measure: Maximum Abduction
timeFrame: Up to One Year
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: Up to One Year
measure: Pediatric Voice Handicap Index
timeFrame: Up to One Year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CCHMC
state: Ohio
Study officials:
affiliation: CCHMC
name: Alessandro de Alarcon, MD
role: PRINCIPAL_INVESTIGATOR
References: