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Completed

NCT Number: NCT06637774

The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

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.

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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center Oakland campus

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirometer

Device

a triaxial accelerometer and a contact microphone affixed with tape to patient neck, a data accrual infrastructure, algorithms that decode swallow physiology noninvasively

Other names: high resolution cervical auscultation

Videofluoroscopic X-ray

Device

MBS is a fluoroscopic diagnostic test to evaluate swallowing physiology. Its images are judged by humans trained to do so.

Other names: Modified barium swallow study (MBS)

Primary outcomes

  1. 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.

  2. 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:

    • no contrast entered the airway
    • shallow laryngeal vestibule penetration of contrast above the vocal folds, NO airway residue observed

    Moderate:

    • shallow laryngeal vestibule penetration above the vocal folds, airway residue IS observed
    • deep laryngeal penetration to the inferior larynx, NO airway residue is observed
    • deep laryngeal penetration to the inferior larynx, airway residue IS observed
    • transient aspiration-contrast enters trachea and is ejected from trachea

    Severe:

    • aspiration with observable tracheal residue, spontaneous airway clearance response ineffective
    • silent aspiration-aspiration-no observed effort or reflexive reaction to clear airway

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Toronto

Registry information

Official study title

The Aspirometer: A Noninvasive Tool for Detecting Aspiration

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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