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Yale Swallow Protocol in Extubated Patients

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ClinicalTrials.gov Identifier: NCT03352908
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease
Dysphagia

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Yale Swallow Protocol in Recently Extubated Patients
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : October 29, 2020
Actual Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Determine the sensitivity of the Yale Swallow Protocol (YSP) through aspiration identification in recently extubated patients. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients recently extubated that are consulted for swallowing assessment by their treating physician.
Criteria

Inclusion Criteria:

  1. Intubation greater than 24 hours
  2. Age 18 and older
  3. All races
  4. Males and females
  5. English speaking
  6. Swallow consult ordered by the team within 48 hours of extubation

Exclusion Criteria:

  1. Known history of oropharyngeal dysphagia
  2. 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.
  3. Allergy to dairy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352908


Locations
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United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Stevie J Marvin, MS University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03352908    
Other Study ID Numbers: 2016-1149
A539772 ( Other Identifier: UW Madison )
SMPH/SURGERY/SPEECH ( Other Identifier: UW Madison )
Protocol Version 9/28/2017 ( Other Identifier: UW Madison )
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Dysphagia
Aspiration
YSP
FEES
Swallow Problems
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases