The Aspirometer: A Noninvasive Tool for Detecting Aspiration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Masking Description
Judges, examiners were blinded to participant diagnosis. Measurement/analysis judges were blinded to participant diagnosis.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •unable to follow verbal commands
- •anatomic disruption of head neck
- •radiation therapy to head or neck
Outcomes
Primary Outcomes
Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result
Time Frame: 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.
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
James Coyle
Professor
University of Pittsburgh