N/A
N=50
The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3
Deglutition Disorders
Bottom Line
View on ClinicalTrials.gov: NCT06637774 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result — 4; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aspirometer (Device); Videofluoroscopic X-ray (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Participants for Which the Aspirometer/HRCA Predicted the Passed Versus Failed Swallow Test Result |
4; 12 | — |
| PRIMARY Percentage of PAS Scores That Were Accurately Predicted by the Aspirometer/HRCA, in Comparison to Modified Barium Swallow Test. |
62 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06637774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.