NCT05166993

Dynamic Electronic Filter for Arterial Waveform Distortion

Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: University of Florence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Underdamping/Resonance Artifacts

Interventions

Type	Name	Description
DEVICE	MostCareUp	Pressure transducers have been connected to the MostCareUp and the hemodynamic parameters compared as follows: no filter, electronic filter, no electronic filter plus Accudynamic (our reference system). Invasive pressure values have been then compared with the non-invasive ones.

Timeline

• Start date: 2017-03-15
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2021-12-22
• Last updated: 2022-01-12

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study