Validation of the Yale Swallow Protocol: A Prospective Double-Blinded Videofluoroscopic Study

Abstract

The purpose of this prospective, double-blinded, multirater, systematic replication study was to investigate agreement for aspiration risk, in the same individual, between videofluoroscopic swallow studies (VFSS) and the Yale Swallow Protocol. Participants were 25 consecutive adults referred for dysphagia testing who met the inclusion criteria of completion of a brief cognitive assessment, oral mechanism examination, and no tracheotomy tube. First, all participants were administered the Yale Swallow Protocol by two experienced speech-language pathologists trained in protocol administration. Failure criteria were inability to drink the entire amount, interrupted drinking, or coughing during or immediately after drinking. Second, all participants completed a VFSS within 5–10 min of protocol administration. A speech-language pathologist, blinded to protocol results, reviewed the VFSS to determine aspiration status in a binary (yes/no) manner. Inter-rater agreement between two speech-language pathologists was 100 % for identification of aspiration risk with the Yale Swallow Protocol. Inter-rater agreement between the speech-language pathologist and the radiologist for identification of aspiration status with VFSS was 100 %. Twenty percent of VFSS recordings were viewed again 3–6 months after initial data collection, and intrarater agreement for identification of thin liquid aspiration was 100 %. Sensitivity for the Yale Swallow Protocol = 100 %, specificity = 64 %, positive predictive value = 78 %, and negative predictive value = 100 %. Importantly, all participants who passed the protocol did not aspirate during VFSS. Multiple, double-blinded raters and VFSS as the reference standard agreed with previous research with a single, nonblinded rater and FEES as the reference standard for identification of aspiration risk. The clinical usefulness and validity of the Yale Swallow Protocol for determining aspiration risk in a small sample size of male participants has been confirmed. Future research is needed with a larger and more heterogeneous population sample.

Appendices

Appendix 1: Yale Swallow Protocol

Step 1: Exclusion Criteria

__ Yale Swallow Protocol Deferred due to NO concern for aspiration risk.

Any YES answer to the following risk factors will also defer administration of protocol:

Yes No

__ __ Unable to remain alert for testing

__ __ Eating a modified diet (thickened liquids) due to pre-existing dysphagia

__ __ Existing enteral tube feeding via stomach or nose

__ __ Head-of-bed restrictions < 30 °

__ __ Tracheotomy tube present

__ __ Nil per os by physician order

If the patient’s clinical status changes resulting in a new risk for aspiration, the protocol must be readministered before oral alimentation or medications are ordered.

Appendix 2: Yale Swallow Protocol

Step 2: Administration Instructions

If patient is deemed an aspiration risk and all exclusion criteria in Step 1 are checked “NO,” proceed with protocol:

• Brief Cognitive Screen:

What is your name?

Where are you right now?

What year is it?

• Oral-Mechanism Examination:

Labial closure

Lingual range of motion

Facial symmetry (smile/pucker)

• Perform the 3-ounce water swallow challenge:

Sit patient upright at 80–90 ° (or as high as tolerated > 30 °).

Ask patient to drink the entire 3 ounces (90 cc) of water from a cup or with a straw, in sequential swallows, and slow and steady but without stopping. (Note: Cup or straw can be held by clinician or patient.) Assess patient for interrupted drinking and coughing or choking during or immediately after completion of drinking.

Note: Information from the brief cognitive screen [5] and oral mechanism examination [6] provide information on odds of aspiration risk with the 3-ounce water swallow challenge and should not be used as exclusionary criteria for screening.

Appendix 3: Yale Swallow Protocol

Step 3: Pass/Fail Criteria

Results and Recommendations

__ PASS: Complete and uninterrupted drinking of all 3 ounces of water without overt signs of aspiration, i.e., coughing or choking, either during or immediately after completion.

• If patient passes, collaborate with MD/PA/LIP to order appropriate oral diet. If dentate, order a soft solid consistency or regular consistency diet. If edentulous, order a liquid and puree diet.

__ FAIL: Inability to drink the entire 3 ounces in sequential swallows due to stopping/starting or patient exhibits overt signs of aspiration, i.e., coughing or choking, either during or immediately after completion.

• If patient fails, keep nil per os (including medications) and discuss with the MD/PA/LIP the need for an objective swallowing evaluation by speech-language pathologist.

• Readminister the protocol in 24 h if patient shows clinical improvement.