跳至主要内容
临床试验/NCT04496986
NCT04496986撤回不适用

Mechanisms, Predictors and Clinical Markers of Dysphagia in Cardiac Surgical Patients

University of Florida0 个研究点开始时间: 2022年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Penetration Aspiration Scale

研究概览

简要总结

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiovascular surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

详细描述

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiovascular surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patients undergoing cardiovascular surgery. The study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status. We will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. If they are found to have dysphagia after surgery, they will be offered no-cost follow up swallow tests at months 1 and 6. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams.

排除标准

  • individuals under the age of 18, 2) patients with a confirmed positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.

结局指标

主要结局

Penetration Aspiration Scale

时间窗: Follow-up - Within 72 hours following extubation from surgery and onward

This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. (Used in both FEES and VFSS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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