Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Identification of Patient's Vibratory Source
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages of 3-30 years,
- •No prior airway surgery
- •Able to undergo the evaluation protocol
排除标准
- •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:
- •Age of 3-30 years
- •No prior history of intubation injury or airway/laryngeal surgery
- •Normal hearing
- •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:
- •Has had airway or laryngeal surgery
- •History of a voice or hearing disorder
- •History of neonatal intubation over 14 days
- •Have a disability that precludes them from completing the evaluation
结局指标
主要结局
Identification of Patient's Vibratory Source
时间窗: Up to One Year
Vibratory source will be rated by having HSV imaging samples subjected to an automatic temporal segmentation, which will extract the HSV segment of interest. The extracted temporal segment (i.e. token) is subjected to an automatic image segmentation based on the oscillating edges of the anatomic structures using kymographic paired active contours. The image segmentation will be aided by an automatic spectral oscillation analysis similar to previously published methods. Three raters will be asked to interpret the image analysis results, which will be overlaid on the HSV image. To identify the patient's vibratory source, among the segmented vibratory areas, the raters will identify which vibratory structure(s)--glottis, false vocal folds, aryepiglottic folds, arytenoid against epiglottis, other supraglottal structures, or any combination of those--could be phonatory/which anatomic structure produced the vibration.
次要结局
- Tissue Health of Patient--Vocal Fold Vibration(Up to One Year)
- Maximum Adduction(Up to One Year)
- Tissue Health of Patient--Scarring of Airway(Up to One Year)
- Pediatric Voice Handicap Index(Up to One Year)
- Maximum Abduction(Up to One Year)
- Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)(Up to One Year)