Trial Outcomes & Findings for The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3 (NCT NCT06637774)

Last Updated: 2025-02-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

day 1

Results posted on

2025-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Videofluoroscopic Swallow Study + Aspirometer 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. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Videofluoroscopic Swallow Study + Aspirometer n=50 Participants 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. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.
Age, Continuous	66.77 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: day 1

Population: Only 23/50 patients produced single discrete swallows during VFS.

Outcome measures

Outcome measures
Measure	Videofluoroscopic Swallow Study + Aspirometer n=23 Participants 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. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.
Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result passed tests	4 Participants
Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result failed tests	12 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Videofluoroscopic Swallow Study + Aspirometer n=85 PAS scores 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. Aspirometer: a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively Videofluoroscopic X-ray: MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.
Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test.	62 PAS scores

Adverse Events

Videofluoroscopic Swallow Study + Aspirometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Coyle

University of Pittsburgh

Phone: 4123836608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place