Dynamic Electronic Filter for Arterial Waveform Distortion

Sponsor
University of Florence (Other)
Overall Status
Completed
CT.gov ID
NCT05166993
Collaborator
(none)
70
1
18
3.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: MostCareUp

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study
Actual Study Start Date :
Mar 15, 2017
Actual Primary Completion Date :
Sep 15, 2018
Actual Study Completion Date :
Sep 15, 2018

Outcome Measures

Primary Outcome Measures

  1. The present study was aimed to test the MostCareUp electronic filter [15 minutes]

    To test the electronic filter comparing the electronically corrected arterial pressure and the derived cardiac output values with those corrected with the Accudynamic, a mechanical adjustable damping device commonly used in clinical practice.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;
Exclusion Criteria:
  • Arrhythmias

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliero-Universitaria Careggi Florence Italy 50134

Sponsors and Collaborators

  • University of Florence

Investigators

  • Study Director: Stefano Romagnoli, Prof, University of Florence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gianluca Villa, Professor, University of Florence
ClinicalTrials.gov Identifier:
NCT05166993
Other Study ID Numbers:
  • 10285
First Posted:
Dec 22, 2021
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jan 12, 2022