Cardiac Output Measurement Clinical Trial
Official title:
Comparison Between MostCare and Echo-Doppler for Cardiac Output Measurement: an Observational Study
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.
(*) Study design
A. MostCare system data acquisition Before each CO measurement, the arterial pressure
catheter and transducer quality will be assessed as follows: easy aspiration of 5 ml of
blood easily re-injected without resistance; visual assessment of the quality of the
arterial waveform contour; adequate response to the flush test (square wave). If necessary,
the best position for the signal quality will be checked by extending the wrist and
manipulating the catheter. For each determination of Echo-Doppler (and ThD-CO when
applicable), a corresponding value for MostCare must be obtained by averaging the individual
beats over the same time necessary to obtain the Echo-doppler-CO (and ThD-CO when
applicable) measurements.
B. Echo-Doppler data acquisition (transoesophageal - TOE - or transthoracic - TTE - echo)
Echo-Doppler-CO will be measured using the standard formula CSA x VTI (cross sectional area
x velocity time integral x heart rate in ml/min). 2D measurement of the aortic annulus
diameter allows calculation of the flow CSA which is then multiplied by the VTI (velocity
time integral) of the Pulsed Doppler flow velocity profile across the aortic valve to
determine the SV.
Other hemodynamic variables as an ancillary part of the study will compare shortening
fraction (SF) or EF fraction from Echocardiography with CCE and dp/dt.
C. Thermodilution data acquisition (ThD-CO) (when applicable) Data coming from ThD pulmonary
artery catheter (PAC) or a CVC + femoral artery catheter (transpulmonary thermodilution,
PiCCO system) will be collected from the monitor itself or the system for patient monitoring
used in the units.
For standard PAC-ThD-CO, five consecutive injections of 10 ml of 5% glucose cold solution
will be randomly injected during respiratory cycle over a 5-min period. Thermodilution-CO
(or PiCCO-CO) will be calculated as the average of the five measurements. All these 5
measurements will be collected.
MostCare, Echo-doppler (and Thermodilution when applicable) Change in ventilator parameters,
sedation drugs, or fluid infusions or vasopressor dose will not be allowed during the
acquisition time.
(*) Study timing and procedure
For each patient CO determinations will be performed as follows:
Mandatory measurements:
• Baseline: (MostCare + Echo-doppler simultaneously, and MostCare + Echo-doppler +
Thermodilution when applicable) = single comparison between techniques.
Recorded but not mandatory measurements (fitting to the therapeutic protocol used in each
center):
• Pre- and post- treatment (fluid challenge, vasoactive drugs and inotropics changes)
(MostCare + Echo-doppler simultaneously, and MostCare + Echo-doppler + Thermodilution when
applicable) = dynamic comparison between techniques (two measures). This will allow a
sub-analysis of CO (the trend of CO) changes, validity of trend, for both SV and CO before
and after a therapeutic intervention.
Data to be collected:
Patient: demographic, anthropometric, pre-medical history, indication(s) for ICU admission;
(cardiovascular diseases and cardiac function, respiratory diseases, etc...), severity
scores (SAPS II, SOFA, ….).
All patients enrolled will be analysed in intention-to-treat even data recording failed. In
this case, that would be a limit if any, for the tested technique.
Hemodynamic MostCare: SV, HR, CO, CCE, ∆P/∆T, ABPs, ABPd, ABPm. Other hemodynamic data: CVP,
PaoP, SvO2, lactate,... Echocardiography: stroke volume, heart rate, cardiac output. Other
hemodynamic variables are allowed to be collected by Echo according to the centre protocols
and the experience of each centre.
Cardiac and vasoactive drugs dose or infusion rate will be collected: dobutamine, dopamine,
norepinephrine, epinephrine, nitrates, beta-blockers, ACE-I,ecc.
Ventilatory: mechanical ventilation settings: mode of ventilation (CPAP, BiPAP, VC, PC),
pressure support (if applicable), peak and plateau pressure, PEEP level, FiO2 oxygenation
(SaO2, PaO2,…) ICU stay and outcome: morbidity (number and type of complications), length of
stay, mortality.
(*) Statistical analysis and methodology, number of patients to be enrolled, duration of the
study:
Collected data will be copied on an excel file to be properly independently analyzed with a
statistical software. Correlation tests (Spearman or Pearson), Student paired t-test, and
Bland-Altman analysis will be applied. A minimum of 30 patients per centre will be enrolled
in the study in a period of 18 months.
This "minimum number" of patients is mandatory as: 1) the enrollment of 30 patients per
centre eliminates the potential bias that may occur when few data come from a single centre,
2) minimum 300 patients enrolled represents a suitable number to obtain the "statistical
power" necessary to validate the comparison between the different methods, and 3) further
analysis and comparisons in subgroup of patients having similar clinical settings can be
performed.
;
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