Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Swallow screen
研究概览
简要总结
Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).
详细描述
The purpose of this research study is to determine if a 3 oz water screening protocol is an effective screen for patients with openings in their airways (i.e. tracheostomies). This procedure is already in use for many different populations and is particularly useful for clinicians who want to understand who is at risk for having food or liquid enter the lungs while eating or drinking (i.e. aspiration).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Has a tracheostomy
- •Able to remain alert for testing
- •Not on a modified diet for pre-existing dysphagia
- •No head of bed restrictions
- •Not NPO by physician for any reason other than possible dysphagia
- •At least 18 years old
排除标准
- •Does not have a tracheostomy
- •Unable to remain alert for testing
- •On a modified diet due to pre-existing dysphagia
- •Head of bed restrictions for greater than or equal to 30 degrees
- •NPO by physician for reasons other than possible dysphagia
- •Less than 18 years old
结局指标
主要结局
Swallow screen
时间窗: End of participation study within 7 days of enrollment
Swallow screen measured as pass/fail for presence or absence of aspiration
Penetration Aspiration Scale Score
时间窗: End of participation study within 7 days of enrollment
The penetration aspiration scale (PAS) is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The PAS is an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events. 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. Higher scores indicate better health outcomes.
次要结局
未报告次要终点
研究者
Miguel Escalon
Associate Professor
Icahn School of Medicine at Mount Sinai