Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Postoperative length of stay (retrospective)
研究概览
简要总结
The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.
详细描述
Pediatric vocal fold motion impairment (VFMI) is a well-known cause of dysphonia and dysphagia. Previous studies have demonstrated the most common etiology for pediatric VFMI is cardiothoracic surgery which is possibly due to a variety of mechanisms.The investigators hypothesize that universal screening of neonates for VMFI following congenital cardiac surgery (CCS) will lead to a more accurate incidence and earlier diagnosis of VFMI. They believe that earlier identification will lead to changes in feeding regimens that may decrease length of stay (LOS), decrease time to oral feeding, earlier otolaryngologic intervention if indicated, and decreased rates of readmission for pulmonary or feeding complications. The investigators will also use this information to design a refined algorithm for targeted screening of patients who are more likely to have VFMI based on patient and surgery characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 18 and younger with congenital cardiac disease necessitating surgery
- •Children 18 and younger whose parents have given and signed an informed consent and HIPAA Authorization as well as the assent of the patient
排除标准
- •History of prior cardiac surgery
- •Known history of VFMI prior to evaluation
- •Children 18 and younger who do not survive the immediate postoperative course will be excluded.
- •Further exclusion may be determined at the discretion of the Principal Investigator.
结局指标
主要结局
Postoperative length of stay (retrospective)
时间窗: Baseline
The number of days of postoperative stay in the hospital will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Number of readmissions related to feeding difficulty (retrospective)
时间窗: Baseline
The number of readmissions to the hospital for feeding difficulties will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Number of readmissions related to aspiration (retrospective)
时间窗: Baseline
The number of readmissions to the hospital for aspiration will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Number of readmissions related to feeding difficulty (prospective)
时间窗: 3 months, 6 months, 12 months
The number of readmissions to the hospital for feeding difficulties will be recorded.
Number of participants with vocal fold motion impairment (prospective)
时间窗: Baseline
The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.
Time to initiation of feeding therapy (retrospective)
时间窗: Baseline
The average time (in days) to start feeding therapy will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.
Postoperative length of stay (prospective)
时间窗: Up to 180 days
The number of days of postoperative stay at the hospital will be recorded.
Time to initiation of feeding therapy (prospective)
时间窗: Day 7
The number of days to start feeding therapy will be recorded.
Number of readmissions related to aspiration (prospective)
时间窗: 3 months, 6 months, 12 months
The number of readmissions to the hospital for aspiration will be recorded.
次要结局
未报告次要终点
研究者
Nikhila Raol
Assistant Professor
Emory University