Skip to main content
OpenTrials
Completed

NCT Number: NCT01806467

Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution

Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Ospedali Riuniti Ancona

Ancona, 60126, Italy

About this study

Hemodynamic monitoring is important in critically ill patients. It is often used to assess a cardiovascular derangements, to help diagnosing the causes and to monitor the response to therapy.

Pulmonary thermodilution (ThD) is still considered the gold standard reference method for cardiac output (CO) measurement [1]. Its invasiveness, however, often limits or delays its application [2, 3]. In the last decades new less invasive hemodynamic monitoring systems have been developed. The majority of such new devices allows for continuous monitoring of CO and other hemodynamic variables [4].

Among the various less invasive techniques, the PiCCO (Pulse-induced Contour Cardiac Output) relies on the concept of the "pulse contour methodology" for providing beat-to-beat CO assessment. This method needs transpulmonary ThD calibration. This is a well validated dilution technique [5]. Another minimally invasive system is the Pressure Recording Analytical Method (PRAM). Unlike other systems with pulse contour analysis, the PRAM does not need external or internal calibration factors since it analyzes the pressure waveform at a frequency of 1000 Hz and computes the patient's cardiovascular system impedance using a mathematical algorithm based on the physical theory of perturbations. It only requires a connection to a femoral or radial artery catheter for the acquisition and analysis of the arterial pressure traces [6]. This new method has been validated under different experimental and clinical settings [6-9]. Limited data are available under conditions of hemodynamic instability [10-12]. So far, its accuracy and reliability in assessing CO in hemodynamically unstable patients needs yet to be clarified.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hemodynamic instability in:

  • septic shock
  • pneumonia
  • polytrauma
  • chronic obstructive pulmonary disease
  • heart failure
  • post operative cardiosurgical patients

Exclusion criteria

  • Atrial fibrillation
  • Pacemaker or implantable cardiac defibrillator
  • Aortic or mitral valve disease
  • Intra-aortic balloon pump

Treatment and study plan

Primary outcomes

  1. Blant-Altman test and coefficient of error of Cardiac Output measured with PRAM towards that measured with thermodilution

    Time frame: Study Period: 9 months

    Agreement between Cardiac Output measured with PRAM and cardiac output measured with thermodilution (both pulmonary and transpulmonary thermodilution) was determined by the Bland-Altman method. The precision of the measurements was given by the limits of agreement (LoA) (±1.96SD) of the mean difference of the methods compared. Upper and lower LoA were calculated as the bias ± 1.96SD. The percentage error was calculated as the LoA of the bias divided by the mean CO from two methods compared. Thirty per cent was considered an a priori criterion of interchangeability.

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

Continuous Thermodilution, Transpulmonary Thermodilution and Pressure Recording Analytical Method for Cardiac Output Measurement During Hemodynamic Instability: a Prospective Clinical Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2013
Registry last updated
Mar 7, 2013

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.

Published trials that share one or more normalized conditions with this study.