Deglutition Disorders
Conditions
Keywords
dysphagia, artificial intelligence, machine learning
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.
Interventions
DEVICEAspirometer
a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively
DEVICEVideofluoroscopic X-ray
MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.
Sponsors
University of Toronto
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
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.
Intervention model description
Prospective study of patients referred for videofluoroscopic swallow study, consenting to parallel data collection of signals. No control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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 * pregnant * unable to follow verbal commands * anatomic disruption of head neck * radiation therapy to head or neck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Videofluoroscopic Swallow Study + Aspirometer |
|---|---|
| Age, Continuous | 66.77 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result
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.
Time frame: day 1
Population: Only 23/50 patients produced single discrete swallows during VFS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Videofluoroscopic Swallow Study + Aspirometer | Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result | passed tests | 4 Participants |
| Videofluoroscopic Swallow Study + Aspirometer | Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result | failed tests | 12 Participants |
Primary
Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test.
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
Time frame: day 1
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Videofluoroscopic Swallow Study + Aspirometer | Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test. | 62 PAS scores |