Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01205594
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2010-09-17
Brief Title:
IRB-HSR 14296 The Use of the Intrathoracic Pressure Regulator ITPR to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
IRB-HSR 14296 The Use of the Intrathoracic Pressure Regulator ITPR to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
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:
Briefly after the induction of anesthesia and the placement of TEE hemodynamic variables pulmonary and systemic blood pressure central and pulmonary venous pressure cardiac output calculated SVR etc will be collected In addition left ventricular performance including estimates of LVEDV LVESV EF FAC etc will be assessed using TEE Once these baseline data are recorded the ITPR will be inserted in the anesthesia circuit and activated to provide -9 mmHg ETP After the ITPR has been active for at least two minutes the same hemodynamic and TEE data obtained above will be gathered After the data is recorded the ITPR will be disconnected and no further interventions will be made In addition to the hemodynamic and echocardiographic data described above an arterial blood gas will be obtained from the pre-existing radial artery catheter during the on- and off- states
Finally the TEE examination will be recorded on videotape or DVD A second echocardiographer blinded to patient and ITPR status will review each echocardiogram and assess left ventricular performance In addition to the data derived at the time of testing the second echocardiographer will assess if possible changes in EF using Simpsons method of disks is used to calculate the LV volume
This is a proof of conceptfeasibility study designed to test the primary hypothesis that use of the ITPR will result in increased systemic blood pressure and cardiac output in patients undergoing CABG surgery The effect of the ITPR on other secondary indicators of cardiac performance will also be examined These include but are not limited to left ventricular end diastolic volume LVEDV ejection fraction EF left ventricular end systolic volume LVESV and fractional area change FAC as assessed by echocardiography pulmonary artery pressure and calculated systemic vascular resistance SVR
Finally the TEE examination will be recorded on videotape or DVD A second echocardiographer blinded to patient and ITPR status will review each echocardiogram and assess left ventricular performance In addition to the data derived at the time of testing the second echocardiographer will assess if possible changes in EF using Simpsons method of disks is used to calculate the LV volume
This is a proof of conceptfeasibility study designed to test the primary hypothesis that use of the ITPR will result in increased systemic blood pressure and cardiac output in patients undergoing CABG surgery The effect of the ITPR on other secondary indicators of cardiac performance will also be examined These include but are not limited to left ventricular end diastolic volume LVEDV ejection fraction EF left ventricular end systolic volume LVESV and fractional area change FAC as assessed by echocardiography pulmonary artery pressure and calculated systemic vascular resistance SVR
Detailed Description:
The 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 SVR The end result is a device that simultaneously improves cardiac output by increasing LVEDPLVEDV and decreasing SVR while increasing coronary perfusion pressure by increasing blood pressure and decreasing LVESPLVESV1-8
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