MostCare Versus Echo-Doppler for Cardiac Output Measurement

NCT01678950 | Completed DMC

• 1 other identifier: PRAM2012
• Study Type: observational
• Target: 400
• Locations: 4 countries
• Sites: 14

Brief Summary

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.

Conditions

Cardiac Output Measurement

Keywords

Cardiac output monitoring; Echocardiography; Pulse contour system

Outcome Measures

Primary Outcomes (1)

• cardiac output

  comparison of cardiac output monitoring systems

  comparison of monitoring systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Intensive Care Unit, under different clinical conditions

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead

Study Sites (14)

Department of Anesthesiology & Intensive Care - Lariboisière University Hospital University Paris 7 Diderot. France

Paris, Paris, 75007, France

Location

Department of Anaesthesia and Intensive Care, Torrette University Hospital

Ancona, Ancona, 60100, Italy

Location

Intensive Care Unit, Santa Maria Annunziata Hospital

Florence, Florence, 50122, Italy

Location

Department of Cardiovascular Anesthesia and Intensive Care, Careggi University Hospital, Italy

Florence, Florence, 50141, Italy

Location

Anaesthesia and Intensive Care Unit, S. Giovanni di Dio - Torregalli Hospital

Florence, Florence, 50143, Italy

Location

Department of Anaesthesia and Intensive Care, Ospedali Riuniti Foggia University Hospital

Foggia, Foggia, 71100, Italy

Location

Cardio-Thoracic-Vascular Anaesthesia and Intensive Care, San Raffaele University Hospital

Milan, Milan, 20132, Italy

Location

Department of Anaesthesia and Intensive Care, Pisa University Hospital

Pisa, Pisa, 56126, Italy

Location

Cardiovascular Anesthesia, Policlinico Umberto I°

Rome, Rome, 00161, Italy

Location

Department of Anaesthesia and Intensive Care, Siena University Hospital

Siena, Siena, 53100, Italy

Location

Policlinico Universitario Padova

Padua, 35128, Italy

Location

Ospedale S. Antonio Abate di Pontremoli

Pontremoli, 54027, Italy

Location

of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario de la Ribera

Valencia, Valencia, 46600, Spain

Location

(Cardiothoracic Anaesthesia, Heart and Lung Centre, New Cross Hospital

Wolverhampton, England, WV10, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

ES (1); GB (1); FR (1); IT (11)