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NCT03900546 Clinical Trial

Arterial Tone Influence on Cardiac Output Measured by PRAM

Critically Ill Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03900546
Other study ID # PRAM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date February 2020

Study information
Verified date March 2020
Source Università Politecnica delle Marche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MostCare
CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason

Locations
Country Name City State
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Ancona

Sponsors (1)
Lead Sponsor Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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