Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01205620
Status:
UNKNOWN
Last Update Posted:
2010-09-20
First Post:
2010-09-17
Brief Title:
IRB-HSR 15084 A Prospective Unblinded Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
IRB-HSR 15084 A Prospective Unblinded Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants undergoing Off-CABG will be randomized 11 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 20 Lminm2 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
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 20 Lminm2 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
Detailed Description:
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 LVESPLVESV7-14
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 LVESPLVESV7-14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None