MedTrace Logo

Dynamic Electronic Filter for Arterial Waveform Distortion

NCT05166993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2022-01-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Principal Investigators

  • Stefano Romagnoli, Prof · University of Florence

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2018-09-15
Completion
2018-09-15
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166993 on ClinicalTrials.gov