Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05166993
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic Electronic Filter for Arterial Waveform Distortion
Sponsor:
University of Florence
Organization:
Study Overview
Official Title:
Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study
Status:
COMPLETED
Status Verified Date:
2021-12
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:
Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.
In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).
In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: