The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

Not Applicable

Completed

Conditions: Deglutition Disorders

Registration Number: NCT06637774

Lead Sponsor: University of Pittsburgh

Brief Summary: This investigation evaluates the effectiveness of a device called the Aspirometer, which uses high resolution cervical auscultation (HRCA), in detecting when food or liquids enter the airway (aspiration) of the person swallowing, whether the person swallowing shows signs of aspiration (coughing) or not.

Detailed Description: This aim of the project seeks to discriminate normal from abnormal airway protection and kinematic functions noninvasively via machine-learning analysis of Aspirometer/HRCA (high resolution cervical auscultation) signals, with similar accuracy as human judgment of VF. Hypothesis: Advanced data analytics can detect pathological airway protection in HRCA signal signatures with 90% accuracy when compared to a human expert's airway protection ratings from VF images. Analytical algorithms that can learn from data (e.g., Bayes' learning) will be used to infer about the continuum of abnormal airway protection during swallowing.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

referred by an attending physician as an inpatient, for a modified barium swallow examination due to suspected dysphagia and aspiration

Exclusion Criteria

tracheostomy
pregnant
unable to follow verbal commands
anatomic disruption of head neck
radiation therapy to head or neck

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result	day 1	Patients will undergo the Yale Swallow Protocol Screening Test and videofluoroscopic swallow study (VFS) while being concurrently monitored by the Aspirometer. Blinded trained human judges will score the screening test per its protocol indicating pass or fail based on the test's manual. Participants then immediately undergo a videofluoroscopic swallowing study during the same visit. Judgments of their penetration-aspiration scale (PAS) scores on the will serve as the gold standard for whether abnormal airway protection occurs during a swallow. The Yale swallow protocol involves a patient suspected of dysphagia with aspiration, drinking an aliquot of water (90mL) from a cup. Patient PASSES the screen if they drink the aliquot continuously without pausing, and if they do not cough or clear their throat after the swallow (one minute observation). Patients who PASS are assumed to NOT aspirate, patients who FAIL are assumed to aspirate.
Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test.	day 1	The Penetration Aspiration Scale is an 8-point ordinal scale validated in 1996. Scale range 1(best)-8(worst). Normal: 1. no contrast entered the airway 2. shallow laryngeal vestibule penetration of contrast above the vocal folds, NO airway residue observed Moderate: 3. shallow laryngeal vestibule penetration above the vocal folds, airway residue IS observed 4. deep laryngeal penetration to the inferior larynx, NO airway residue is observed 5. deep laryngeal penetration to the inferior larynx, airway residue IS observed 6. transient aspiration-contrast enters trachea and is ejected from trachea Severe: 7. aspiration with observable tracheal residue, spontaneous airway clearance response ineffective 8. silent aspiration-aspiration-no observed effort or reflexive reaction to clear airway