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Completed

NCT Number: NCT03900546

Arterial Tone Influence on Cardiac Output Measured by PRAM

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.

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Key information

Conditions

Cardiac Output Critical Illness Critically Ill Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MostCare

Device

CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason

Primary outcomes

  1. Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2019
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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