The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability for the ProLung Test and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test

The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03993028

Enrollment

Registered

2019-06-20

Start date

2015-11-20

Completion date

2018-11-21

Last updated

2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

Assess the repeatability of the ProLung Test

Detailed description

This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same device. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 35 to 70 years * Able to understand and fulfill all requirements of this protocol * Provide signed informed consent

Exclusion criteria

* Pacemaker or other implanted medical device * Current life-threatening medical condition * Current or recent use of systemic corticosteroids * Pregnant or lactating * Unusually strenuous exercise within previous 24 hours * Current abuse of alcohol or drugs * Medical or anatomical condition that precludes testing of all 62 measurement points * Other condition or reason at the discretion of the Principal Investigator or medical monitor

Design outcomes

Primary

Measure	Time frame	Description
Quantify EPN Scanner variability in transcutaneous volume-averaged thoracic bio-conductance when measured twice on the same subjects by the same operator on a single same day using the same EPN Scanner	1 day	The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same day).
Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week.	1 week	The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days).
Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance	1 week	The null hypothesis is that BMI has no effect on scan results. The null hypothesis is that sex has no effect on scan results.
Number of participants with device-related adverse events from thoracic bio-conductance measurement.	1 day	time to complete scan.

Outcome results