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

This study is currently recruiting participants.
Verified September 2012 by Azienda Ospedaliera Universitaria Senese
Sponsor:
Information provided by (Responsible Party):
Sabino Scolletta, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier:
NCT01678950
First received: August 31, 2012
Last updated: September 11, 2012
Last verified: September 2012
  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
MostCare Versus Echo-Doppler for Cardiac Output Measurement. The Subjects Enrolled in the Study Will be Under Different Clinical Conditions.

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:

Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
  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
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 Recruiting
Paris, France, 75007
Contact: Didier Payen, MD    0033.1.4995 9113    dpayen1234@orange.fr   
Italy
Department of Anaesthesia and Intensive Care, Torrette University Hospital Recruiting
Ancona, Italy, 60100
Contact: Abele Donati, MD    0039 071 5964645    a.donati@univpm.it   
Department of Cardiovascular Anesthesia and Intensive Care, Careggi University Hospital, Italy Recruiting
Florence, Italy, 50141
Contact: Stefano Romagnoli, MD    0039 335 61005535    romagnoliste@tiscali.it   
Intensive Care Unit, Santa Maria Annunziata Hospital Recruiting
Florence, Italy, 50122
Contact: Maria Diletta Guarducci, MD       diletta.guarducci@asf.toscana.it   
Anaesthesia and Intensive Care Unit, Mugello - Borgo S. Lorenzo Hospital Recruiting
Florence, Italy, 50032
Contact: Roberto Oggioni, MD       , roberto.oggioni@asf.toscana.it   
Anaesthesia and Intensive Care Unit, S. Giovanni di Dio - Torregalli Hospital Recruiting
Florence, Italy, 50143
Contact: Marco Morelli, MD       marco.morelli@asf.toscana.it   
Department of Anaesthesia and Intensive Care, Ospedali Riuniti Foggia University Hospital Recruiting
Foggia, Italy, 71100
Contact: Lucia Mirabella, MD       lumirabe@yahoo.it   
Cardio-Thoracic-Vascular Anaesthesia and Intensive Care, San Raffaele University Hospital Recruiting
Milan, Italy, 20132
Contact: Giulia Maj, MD    0039.02.2643 7117    giulia_maj@yahoo.it   
Department of Anaesthesia and Intensive Care, Pisa University Hospital Recruiting
Pisa, Italy, 56126
Contact: Francesco Forfori, MD    0039 347 4567659    forforiden@libero.it   
Cardiovascular Anesthesia, Policlinico Umberto I° Recruiting
Rome, Italy, 00161
Contact: Luigi Tritapepe, MD       luigi.tritapepe@uniroma1.it   
Department of Anaesthesia and Intensive Care, Siena University Hospital Recruiting
Siena, Italy, 53100
Contact: Sabino Scolletta, MD    0039 338 9842199    scolletta@unisi.it   
Department of Anaesthesia and Intensive Care, Borgo Trento University Hospital Recruiting
Verona, Italy, 37126
Contact: Alessandro Devigili, MD       cipalessandro@libero.it   
Spain
of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario de la Ribera Recruiting
Valencia, Spain, 46600
Contact: Jose Alonso-Iñigo, MD       jmalonso-inigo@ono.com   
United Kingdom
(Cardiothoracic Anaesthesia, Heart and Lung Centre, New Cross Hospital Recruiting
Wolverhampton, England, United Kingdom, WV10
Contact: Giampaolo Martinelli, MD    0044 1902 694357    giampaolo.martinelli@nhs.net   
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: September 11, 2012
Health Authority: Italy: Ministry of Health
France: Ministry of Health
Germany: Ministry of Health
Spain: Ministry of Health

ClinicalTrials.gov processed this record on April 17, 2014