Yale Swallow Protocol in Extubated Patients
Yale Swallow Protocol in Recently Extubated Patients
4 other identifiers
observational
166
1 country
1
Brief Summary
The purpose of this study is to determine if the Yale Swallow Protocol is an effective screen for aspiration in recently extubated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2017
CompletedFirst Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2020
CompletedSeptember 14, 2021
September 1, 2021
3 years
October 30, 2017
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the sensitivity of the Yale Swallow Protocol (YSP) through aspiration identification in recently extubated patients.
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
Assessing the sensitivity of YSP within 2 study visit, within 2 hours. Data will be reported at study completion, an average of 1 year.
Study Arms (2)
YSP
The Yale Swallow Protocol (YSP) consists of a brief cognitive screen, a brief oral motor exam, and a 3oz water challenge (subjects instructed to drink 3oz of water without stopping). Pass/fail is determined based on the subjects ability to drink the 3oz of water uninterrupted without immediate cough.
FEES
Flexible Endoscopic Evaluation of Swallowing (FEES) uses a flexible endoscope that will be passed transnasally into the pharynx by a speech pathologist specializing in dysphagia management. FEES will be treated as a placebo comparator.
Eligibility Criteria
Inpatients recently extubated that are consulted for swallowing assessment by their treating physician.
You may qualify if:
- Intubation greater than 24 hours
- Age 18 and older
- All races
- Males and females
- English speaking
- Swallow consult ordered by the team within 48 hours of extubation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stevie J Marvin, MS
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 24, 2017
Study Start
October 25, 2017
Primary Completion
October 29, 2020
Study Completion
October 29, 2020
Last Updated
September 14, 2021
Record last verified: 2021-09