CABG Clinical Trial
Official title:
IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery
Participants undergoing Off-CABG will be randomized 1:1 to one of the following groups:
- treatment with CirQlator TM Intrathoracic Pressure Regulator (ITPR)
- no ITPR .Anesthesia will be standardized for both groups. The groups will be compared
based on the differences in vasopressor use, the number and amount (in milliliters) of
intravenous fluid boluses required and hemodynamic changes noted, including systemic
blood pressure, pulmonary arterial pressure, pulse pressure, heart rate (recorded most
reliably from the arterial line), cardiac output (CO), cardiac index (CI), mixed venous
oxygen saturation (SVO2), SVR, pulmonary vascular resistance (PVR), and stroke volume
(SV).
Specifically, we will compare the groups based on the mean number of intravenous fluid
boluses, mean amount of norepinephrine and epinephrine infusion required, the number of
recorded systolic blood pressures < 90 mmHg, and number of CI < 2.0 L/min/m2. We will also
compare the number of times the surgeon must reposition the heart for treatment of
hypotension, and ascertain whether the ITPR will help patients tolerate the cardiac
displacement better, thus decreasing the time required to complete the bypass graft
anastamosis. ECG will be monitored intraoperatively for signs of ischemia including ST
changes, greater than 1mm depression or elevation. Postoperatively, we will record the need
for and amount of diuretic required.
We hypothesize that in this pilot study, patients undergoing OPCAB who are treated with
CirQlator TM Intrathoracic Pressure Regulator (ITPR) will achieve higher blood pressures and
cardiac output and require less intravenous fluids and vasopressor administration than
patients managed without the ITPR.
A new method to improve cardiac performance during OPCAB surgery is needed in order to avoid
the administration of large amounts of intravenous volume, reduce vasopressor medications,
and thus improve cardiac function and reduce the need for postoperative diuresis.
The CirQlator TM Intrathoracic Pressure Regulator (ITPR) is an FDA-approved device intended
to increase circulation and blood pressure in hypovolemic and cardiogenic shock. The device
is inserted within a standard respiratory circuit between the patient and the ventilator. It
functions by decreasing intrathoracic pressure during the expiratory phase to subatmospheric
levels after each positive pressure ventilation. The decrease in intrathoracic pressure
creates a vacuum within the thorax relative to the rest of the body thereby enhancing blood
return to the heart and consequently increasing cardiac output and blood pressure.
Activation of the device is also accompanied by a decrease in systemic vascular resistance
(SVR). The end result is a device that simultaneously improves cardiac output by increasing
preload and decreasing systemic vascular resistance (SVR) while increasing coronary
perfusion pressure by increasing blood pressure and decreasing left ventricular end systolic
pressure and volume (LVESP/LVESV).7-14
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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