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Arterial Tone Influence on Cardiac Output Measured by PRAM

Sponsor
Università Politecnica delle Marche (Other)
Overall Status
Completed
CT.gov ID
NCT03900546
Collaborator
(none)
31
Enrollment
1
Location
71.1
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.

Condition or Disease Intervention/Treatment Phase
  • Device: MostCare

Detailed Description

Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.

Study Design

Study Type:
Observational
Actual Enrollment :
31 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Influence of Arterial Tone Changes on Cardiac Output Measurement by Pressure Recording Analytical Method
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM [Before and 30 minutes after noradrenaline dose variation]

    Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • invasive blood pressure monitoring on site

  • need to start or change the dose of noradrenaline infusion for clinical reason

Exclusion Criteria:

  • age <18

  • arrhythmia

  • severe valvular insufficiency

  • pregnancy

  • low quality arterial signal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Ancona Italy

Sponsors and Collaborators

  • Università Politecnica delle Marche

Investigators

  • Principal Investigator: Abele Donati, MD, PhD, Università Politecnica delle Marche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abele Donati, MD, Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT03900546
Other Study ID Numbers:
  • PRAM
First Posted:
Apr 3, 2019
Last Update Posted:
Mar 25, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Critical Illness

Study Results

No Results Posted as of Mar 25, 2020