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IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery
| Tracking Information | ||||
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| First Received Date ICMJE | September 17, 2010 | |||
| Last Updated Date | August 9, 2011 | |||
| Start Date ICMJE | May 2009 | |||
| Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
hemodynamic variables [ Time Frame: baseline & 2 minutes post device activation ] hemodynamic variables (pulmonary and systemic blood pressure, central and pulmonary venous pressure, cardiac output, calculated SVR) will be collected at baseline & 2 minutes post device activation |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01205594 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
left ventricular performance [ Time Frame: baseline &2 minutes after activation of the device ] left ventricular performance (including estimates of LVEDV, LVESV, EF, FAC, etc.) will be assessed using TEE. |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery | |||
| Official Title ICMJE | IRB-HSR# 14296 The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Systemic Blood Pressure in Patient Undergoing CABG Surgery | |||
| 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 Simpson's method of disks is used to calculate the LV volume. This is a proof of concept/feasibility 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). |
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| 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 LVEDP/LVEDV and decreasing SVR while increasing coronary perfusion pressure by increasing blood pressure and decreasing LVESP/LVESV.1-8 | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Coronary Artery Disease | |||
| Intervention ICMJE | Device: ITPR
the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP. |
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| Study Arms | Experimental: ITPR device
the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP.
Intervention: Device: ITPR |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 20 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01205594 | |||
| Other Study ID Numbers ICMJE | 14296 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Edward C. Nemergut MD, University of Virginia Anesthesiology | |||
| Study Sponsor ICMJE | University of Virginia | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | University of Virginia | |||
| Verification Date | August 2011 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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