The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

University of Pittsburgh

Status: Completed

Conditions: Deglutition Disorders

Treatments: Device: Videofluoroscopic X-ray; Device: Aspirometer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06637774

STUDY22040175 (Aim 3)

R01HD074819 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Videofluoroscopic Swallow Study + Aspirometer

Experimental group

Description:

Consecutively referred patients for modified barium swallow due to suspicion of dysphagia with aspiration, undergo the modified barium swallow test with Aspirometer sensors taped to the anterior neck. Signals are time-linked to images.

Treatment:

Device: Aspirometer

Device: Videofluoroscopic X-ray