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临床试验/NCT03352908
NCT03352908已完成不适用

Yale Swallow Protocol in Recently Extubated Patients

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2017年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
166
试验地点
1
主要终点
Determine the sensitivity of the Yale Swallow Protocol (YSP) through aspiration identification in recently extubated patients.

研究概览

简要总结

The purpose of this study is to determine if the Yale Swallow Protocol is an effective screen for aspiration in recently extubated patients.

详细描述

Dysphagia is prevalent in recently extubated patients with estimates ranging from 29-84% of recently extubated patients having some form of dysphagia with elevated risk for silent aspiration.One challenge providers face when managing post extubation dysphagia (PED) is that there are no best practice guidelines on how to evaluate for PED, specifically how to evaluate for silent aspiration (aspiration without cough response).

One method that has been suggested is the Yale Swallow Protocol (YSP), a pass/fail screen for aspiration consisting of a three ounce water challenge as well as a brief cognitive screen and oral motor exam. The assumption of the YSP is that silent aspiration (aspiration without a cough response) is volume dependent. This is based on a study of over 4000 patients that underwent both a FEES (5mL puree and 5mL liquid boluses) and a 3oz water challenge. Results from previous literature indicated that the 3oz water swallow had a high sensitivity for detecting aspiration (98%). This was again studied with a double blind research design with 25 patients, comparing results of the 3oz water challenge with results of videofluoroscopic swallow study. This showed 100% sensitivity for detecting aspiration, 64% specificity, 78% positive predictive value, and 100% negative predictive value. However, no published study has evaluated the YSP in recently extubated patients and so it is unclear if the high sensitivity and specificity would be retained. Investigators aim to determine the sensitivity and specificity of the Yale Swallow Protocol in identifying aspiration in recently extubated patients.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Intubation greater than 24 hours
  • Age 18 and older
  • Males and females
  • English speaking
  • Swallow consult ordered by the team within 48 hours of extubation

排除标准

  • Known history of oropharyngeal dysphagia
  • Contraindication for FEES due to facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk, reduced level of alertness, or significant agitation.
  • Allergy to dairy

结局指标

主要结局

Determine the sensitivity of the Yale Swallow Protocol (YSP) through aspiration identification in recently extubated patients.

时间窗: Assessing the sensitivity of YSP within 2 study visit, within 2 hours. Data will be reported at study completion, an average of 1 year.

Participants will receive FEES and YSP in a randomized order within a 2 hours of one another. Sensitivity estimates and analysis will be obtained through confidence intervals

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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