Arterial Tone Influence on Cardiac Output Measured by PRAM

Influence of Arterial Tone Changes on Cardiac Output Measurement by Pressure Recording Analytical Method

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Cardiac Output
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM	Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline	Before and 30 minutes after noradrenaline dose variation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: PRAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No