Return of Aspiration-Free Swallow After Laryngotracheal Anesthesia (LTA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Modified functional endoscopic exam of swallowing (FEES)
研究概览
简要总结
Patients undergo laryngotracheal anesthesia (LTA) for a variety of in-office laryngology procedures. Prior to resolution of laryngeal sensory anesthesia, oral intake may predispose patients to aspiration. The purpose of this study is to objectively characterize a time period for return of aspiration-free swallow after LTA.
详细描述
Swallowing is a complex process involving coordination of multiple muscle groups. Sensation in the throat is very important for swallowing safely. Laryngotracheal anesthetic (LTA, or topical application of lidocaine anesthetic to larynx and trachea) is needed for a variety of in-office laryngology procedures, including examination of the air passage, or tracheobronchoscopy. This causes a temporary decrease in sensation that can affect swallow function and result in aspiration (passage of swallowed material into lungs instead of into esophagus and stomach). It is not known how long this effect lasts. It would be helpful to know this for counseling patients on when they can resume swallowing after a procedure. In general, most patients are advised to avoid eating/drinking for 90 minutes after their procedure to allow for sensation to return. To date, there has been no study characterizing the time required for return of aspiration-free swallow after LTA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Ability of patients to speak and understand English
- •Ability for patients to consent for themselves
- •Undergoing tracheobronchoscopy procedure for the treatment of airway stenosis
- •Eating Assessment Tool (EAT-10) score ≤ 3
排除标准
- •Age less than 18 years
- •Patients unable or unwilling to provide informed consent
- •Women who are pregnant
- •History of abnormal swallowing evaluation, either videofluroscopic study of swallow or functional endoscopic evaluation of swallowing (FEES)
- •History of medical condition affecting swallowing, such as
- •Neurodegenerative disorders: stroke, traumatic brain injury, dementia, motor neuron disease, myasthenia gravis, cerebral palsy, Gullain-Barre syndrome, poliomyelitis, myopathy, Parksonism, Huntingon's disease, progressive supranuclear palsy, Wilson's disease, vocal fold paralysis
- •Connective tissue disorders: polymyositis, dermatomyositis, progressive systemic sclerosis, Sjogren's disease, scleroderma
- •History of gastroesophageal tumor
- •History of gastroesophageal surgery
- •History of recent open central neck surgery (i.e., thyroidectomy, anterior cervical discectomy or fusion)
- •History of head and neck cancer
- •History of head and neck radiation therapy or chemotherapy
结局指标
主要结局
Modified functional endoscopic exam of swallowing (FEES)
时间窗: Up to 90 minutes
A modified functional endoscopic exam of swallowing (FEES) is an examination where a small amount of water will be ingested. Each subject will perform about three water swallows. Water will be dyed with green food coloring to facilitate visualization, as is standard with the FEES procedure. If the water passes normally to the esophagus, this will be considered a pass; if the water is aspirated, this will be considered a fail.
次要结局
未报告次要终点
研究者
Blake Simpson
Principal Investigator
University of Alabama at Birmingham