Dynamic Electronic Filter for Arterial Waveform Distortion

NCT ID: NCT05166993

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2018-09-15

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).

Conditions

Underdamping/Resonance Artifacts

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;

Exclusion Criteria

• Arrhythmias

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Villa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Romagnoli, Prof

Role: STUDY_DIRECTOR

University of Florence

Locations

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Countries

Italy

Other Identifiers

10285

Identifier Type: -

Identifier Source: org_study_id