MostCare Versus Echo-Doppler for Cardiac Output Measurement (PRAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sabino Scolletta, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier:
NCT01678950
First received: August 31, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed: the MostCare system. This monitoring system is powered by Pressure Recording Analytical Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal recorded invasively in radial, brachial, or femoral arteries. The most innovative features of this method are: 1) the lack of a calibration requirement, 2) the analysis of the arterial wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm. The investigators primary end-point was to evaluate the relationship between Cardiac Output (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU) patients under different clinical conditions. As a secondary end-point the investigators evaluated the relationship between CO measured by MostCare with CO obtained with thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution, i.e. PiCCO system). This is a prospective multicentre observational study.


Condition
Cardiac Output Measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between MostCare and Echo-Doppler for Cardiac Output Measurement: an Observational Study

Further study details as provided by Azienda Ospedaliera Universitaria Senese:

Primary Outcome Measures:
  • cardiac output [ Time Frame: comparison of monitoring systems ] [ Designated as safety issue: No ]
    comparison of cardiac output monitoring systems


Enrollment: 400
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in Intensive Care Unit, under different clinical conditions

Criteria

Inclusion Criteria:

  • Patients equipped with a standard arterial catheter-line (femoral or radial artery) for invasive arterial blood pressure monitoring.
  • Patients requiring an echocardiographic evaluation - Transthoracic Echocardiographic Evaluation (TEE)or Transesophageal Echocardiographic Evaluation (TOE) - as a routine need or in the context of Acute Cardiocirculatory failure with suspected implication of cardiac dysfunction or Acute Respiratory failure and suspicion of cardiac failure.
  • *When a pulmonary artery catheter (PAC, standard bolus thermodilution, ThD) is used or a central venous catheter linked with a femoral artery catheter to measure the transpulmonary thermodilution (PiCCO system: Continuous pulse contour cardiac analysis), the comparison will be done as a secondary end point of the protocol.

    • The point n.3 is optional

Exclusion Criteria:

  • Related to MostCare:

pathologies that could affect the quality and reliability of the arterial signal (aortic valve pathologies, aortic aneurysms) and arrhythmias that generate hemodynamic instability (i.e., variations in mean BP measurements > 10%); poor quality of the arterial pressure signal after a standard flush test (i.e., over-damped or under-damped arterial trace).

  • Related to Echo-Doppler: non-feasibility to obtain a fulfilled quality of the images.
  • Patients younger than 18.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678950

Locations
France
Department of Anesthesiology & Intensive Care - Lariboisière University Hospital University Paris 7 Diderot. France
Paris, France, 75007
Italy
Department of Anaesthesia and Intensive Care, Torrette University Hospital
Ancona, Italy, 60100
Anaesthesia and Intensive Care Unit, S. Giovanni di Dio - Torregalli Hospital
Florence, Italy, 50143
Intensive Care Unit, Santa Maria Annunziata Hospital
Florence, Italy, 50122
Department of Cardiovascular Anesthesia and Intensive Care, Careggi University Hospital, Italy
Florence, Italy, 50141
Department of Anaesthesia and Intensive Care, Ospedali Riuniti Foggia University Hospital
Foggia, Italy, 71100
Cardio-Thoracic-Vascular Anaesthesia and Intensive Care, San Raffaele University Hospital
Milan, Italy, 20132
Policlinico Universitario Padova
Padova, Italy, 35128
Department of Anaesthesia and Intensive Care, Pisa University Hospital
Pisa, Italy, 56126
Ospedale S. Antonio Abate di Pontremoli
Pontremoli, Italy, 54027
Cardiovascular Anesthesia, Policlinico Umberto I°
Rome, Italy, 00161
Department of Anaesthesia and Intensive Care, Siena University Hospital
Siena, Italy, 53100
Spain
of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario de la Ribera
Valencia, Spain, 46600
United Kingdom
(Cardiothoracic Anaesthesia, Heart and Lung Centre, New Cross Hospital
Wolverhampton, England, United Kingdom, WV10
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
  More Information

No publications provided

Responsible Party: Sabino Scolletta, MD, Principal Investigator, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT01678950     History of Changes
Other Study ID Numbers: PRAM2012
Study First Received: August 31, 2012
Last Updated: June 24, 2014
Health Authority: Italy: Ministry of Health
France: Ministry of Health
Spain: Ministry of Health
United Kingdom: Research Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria Senese:
Cardiac output monitoring
Echocardiography
Pulse contour system

ClinicalTrials.gov processed this record on September 30, 2014