Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665011
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2020-12-08
Brief Title:
Validation of Indicor Photoplethysmography PPG Valsalva Pulse Response vs Non-invasive Blood Pressure
Sponsor:
Vixiar Medical Inc
Organization:
Vixiar Medical Inc
Study Overview
Official Title:
Validation of Indicor Photoplethysmography PPG Valsalva Pulse Response vs Non-invasive Blood Pressure
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study designed is compare the pulse response to the Valsalva maneuver between a photoplethysmography sensor PPG and non-invasive blood pressure sensor for the purpose of validating the PPG methodology in deriving a value for the Valsalva pulse response The aim is to show that the PPG method captures the same phase responses as the blood pressure monitor and the primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse
Detailed Description:
With both a photoplethysmography PPG Indicor Vixiar Medical Baltimore MD and non-invasive blood pressure Caretaker Caretaker Medical Charlottesville VA sensors in place on the index and middle fingers respectively each patient will be asked to perform three mild 10-sec Valsalva maneuvers with at least 45 seconds between Pulse recordings will be collected from each device to compare phases of the Valsalva pulse response including pulse amplitude changes and baseline movement The primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None