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| ID | Type | Description | Link |
|---|---|---|---|
| Study 24328 | Other Identifier | Penn State Health Penn State Hershey Medical Center |
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To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF >40%) for group one and those with moderately to severely reduced LVEF (<40%) in the second group.
Following group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | (LVEF>40%) |
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| Group 2 | (LVEF<40%), |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a change in operating room table position, which will mimic an IV fluid bolus | Other | Cardiac Output (CO) measurements will be obtained at two separate time points: prior to sternotomy (opening of the chest) and after separation from cardiopulmonary bypass. Intervention
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| Measure | Description | Time Frame |
|---|---|---|
| To determine an appropriate cut-off value for the SVC-CI in participants with CAD undergoing isolated CABG to distinguish volume responders from non-responders. |
| 10 minutes of time added to your surgery time. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Stredny, MD | Contact | 717-531-8521 | estredny@pennstatehealth.psu.edu | |
| Cynthia Reed, BS | Contact | 717-531-0003 | 282465 | creed@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward Stredny, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Charbonneau H, Riu B, Faron M, et al. Predicting preload responsiveness using simultaneous recordings of inferior and superior vena cavae diameters. Crit Care. 2014;18(5):473. 2. Hrishi AP, Sethuraman M, Menon G. Quest for the holy grail: Assessment of echo-derived dynamic parameters as predictors of fluid responsiveness in patients with acute aneurysmal subarachnoid hemorrhage. Ann Card Anaesth. 2018;21(3):243-248. 3. Vieillard-Baron A, Chergui K, Rabiller A, et al. Superior vena caval collapsibility as a gauge of volume status in ventilated septic patients. Intensive Care Med. 2004;30(9):1734-1739. 4. Vignon P, Repessé X, Bégot E, et al. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017;195(8):1022-1032. |
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It will depend if the data is shared in data bases and what kind of data bases. this has not been determined.
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