The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

NCT06637774 | Completed Results

• 2 other identifiers: STUDY22040175 (Aim 3)R01HD074819
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders

Keywords

dysphagia; artificial intelligence; machine learning

Outcome Measures

Primary Outcomes (2)

• 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.

  day 1

• 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

  day 1

Study Arms (1)

Videofluoroscopic Swallow Study + Aspirometer

EXPERIMENTAL

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.

Device: Aspirometer; Device: Videofluoroscopic X-ray

Interventions

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

Also known as: high resolution cervical auscultation

Videofluoroscopic Swallow Study + Aspirometer

Videofluoroscopic X-ray DEVICE

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

Also known as: Modified barium swallow study (MBS)

Videofluoroscopic Swallow Study + Aspirometer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- referred by an attending physician as an inpatient, for a modified barium swallow examination due to suspected dysphagia and aspiration

You may not qualify if:

• tracheostomy
• pregnant
• unable to follow verbal commands
• anatomic disruption of head neck
• radiation therapy to head or neck

Sponsors & Collaborators

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

Study Sites (1)

University of Pittsburgh Medical Center Oakland campus

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (15)

• Khalifa Y, Mahoney AS, Lucatorto E, Coyle JL, Sejdic E. Non-Invasive Sensor-Based Estimation of Anterior-Posterior Upper Esophageal Sphincter Opening Maximal Distension. IEEE J Transl Eng Health Med. 2023 Feb 20;11:182-190. doi: 10.1109/JTEHM.2023.3246919. eCollection 2023.

  PMID: 36873304 BACKGROUND

• Mahoney AS, Khalifa Y, Lucatorto E, Sejdic E, Coyle JL. Cervical Vertebral Height Approximates Hyoid Displacement in Videofluoroscopic Images of Healthy Adults. Dysphagia. 2022 Dec;37(6):1689-1696. doi: 10.1007/s00455-022-10414-8. Epub 2022 Mar 1.

  PMID: 35230537 BACKGROUND

• Schwartz R, Khalifa Y, Lucatorto E, Perera S, Coyle J, Sejdic E. A Preliminary Investigation of Similarities of High Resolution Cervical Auscultation Signals Between Thin Liquid Barium and Water Swallows. IEEE J Transl Eng Health Med. 2021 Dec 10;10:4900109. doi: 10.1109/JTEHM.2021.3134926. eCollection 2022.

  PMID: 34963825 BACKGROUND

• Shu K, Coyle JL, Perera S, Khalifa Y, Sabry A, Sejdic E. Anterior-posterior distension of maximal upper esophageal sphincter opening is correlated with high-resolution cervical auscultation signal features. Physiol Meas. 2021 Apr 6;42(3). doi: 10.1088/1361-6579/abe7cb.

  PMID: 33601360 BACKGROUND

• Donohue C, Khalifa Y, Perera S, Sejdic E, Coyle JL. A Preliminary Investigation of Whether HRCA Signals Can Differentiate Between Swallows from Healthy People and Swallows from People with Neurodegenerative Diseases. Dysphagia. 2021 Aug;36(4):635-643. doi: 10.1007/s00455-020-10177-0. Epub 2020 Sep 5.

  PMID: 32889627 BACKGROUND

• Sejdic E, Malandraki GA, Coyle JL. Computational deglutition: Signal and image processing methods to understand swallowing and associated disorders. IEEE Signal Process Mag. 2019 Jan;36(1):138-146. doi: 10.1109/MSP.2018.2875863. Epub 2018 Dec 25. No abstract available.

  PMID: 31631954 BACKGROUND

• Khalifa Y, Donohue C, Coyle JL, Sejdic E. Autonomous Swallow Segment Extraction Using Deep Learning in Neck-Sensor Vibratory Signals From Patients With Dysphagia. IEEE J Biomed Health Inform. 2023 Feb;27(2):956-967. doi: 10.1109/JBHI.2022.3224323. Epub 2023 Feb 3.

  PMID: 36417738 BACKGROUND

• Donohue C, Khalifa Y, Mao S, Perera S, Sejdic E, Coyle JL. Characterizing Swallows From People With Neurodegenerative Diseases Using High-Resolution Cervical Auscultation Signals and Temporal and Spatial Swallow Kinematic Measurements. J Speech Lang Hear Res. 2021 Sep 14;64(9):3416-3431. doi: 10.1044/2021_JSLHR-21-00134. Epub 2021 Aug 24.

  PMID: 34428093 BACKGROUND

• Donohue C, Khalifa Y, Mao S, Perera S, Sejdic E, Coyle JL. Establishing Reference Values for Temporal Kinematic Swallow Events Across the Lifespan in Healthy Community Dwelling Adults Using High-Resolution Cervical Auscultation. Dysphagia. 2022 Jun;37(3):664-675. doi: 10.1007/s00455-021-10317-0. Epub 2021 May 20.

  PMID: 34018024 BACKGROUND

• Sabry A, Mahoney AS, Mao S, Khalifa Y, Sejdic E, Coyle JL. Automatic Estimation of Laryngeal Vestibule Closure Duration Using High- Resolution Cervical Auscultation Signals. Perspect ASHA Spec Interest Groups. 2020 Dec;5(6):1647-1656. doi: 10.1044/2020_persp-20-00073. Epub 2020 Dec 14.

  PMID: 35937555 BACKGROUND

• Mao S, Sabry A, Khalifa Y, Coyle JL, Sejdic E. Estimation of laryngeal closure duration during swallowing without invasive X-rays. Future Gener Comput Syst. 2021 Feb;115:610-618. doi: 10.1016/j.future.2020.09.040. Epub 2020 Sep 30.

  PMID: 33100445 BACKGROUND

• Coyle JL, Sejdic E. High-Resolution Cervical Auscultation and Data Science: New Tools to Address an Old Problem. Am J Speech Lang Pathol. 2020 Jul 10;29(2S):992-1000. doi: 10.1044/2020_AJSLP-19-00155. Epub 2020 Jul 10.

  PMID: 32650655 BACKGROUND

• Khalifa Y, Coyle JL, Sejdic E. Non-invasive identification of swallows via deep learning in high resolution cervical auscultation recordings. Sci Rep. 2020 May 26;10(1):8704. doi: 10.1038/s41598-020-65492-1.

  PMID: 32457331 BACKGROUND

• Donohue C, Mao S, Sejdic E, Coyle JL. Tracking Hyoid Bone Displacement During Swallowing Without Videofluoroscopy Using Machine Learning of Vibratory Signals. Dysphagia. 2021 Apr;36(2):259-269. doi: 10.1007/s00455-020-10124-z. Epub 2020 May 17.

  PMID: 32419103 BACKGROUND

• Zhang Z, Perera S, Donohue C, Kurosu A, Mahoney AS, Coyle JL, Sejdic E. The Prediction of Risk of Penetration-Aspiration Via Hyoid Bone Displacement Features. Dysphagia. 2020 Feb;35(1):66-72. doi: 10.1007/s00455-019-10000-5. Epub 2019 Mar 27.

  PMID: 30919104 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: James Coyle
• Organization: University of Pittsburgh

jcoyle@pitt.edu

4123836608

Study Officials

• James Coyle

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Judges, examiners were blinded to participant diagnosis. Measurement/analysis judges were blinded to participant diagnosis.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective study of patients referred for videofluoroscopic swallow study, consenting to parallel data collection of signals. No control group.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 15, 2024
• Study Start: September 30, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)