MostCare Versus Echo-Doppler for Cardiac Output Measurement (PRAM)
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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.
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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 |
| 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 |
Patients in Intensive Care Unit, under different clinical conditions
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| 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 | |
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 May 19, 2013