Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645327
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Utility of the Superior Vena Cava Collapsibility Index SVC-CI to Predict Fluid Responsiveness in Patients with Coronary Artery Disease Undergoing Surgical Revascularization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utility of the Superior Vena Cava Collapsibility Index SVC-CI to Predict Fluid Responsiveness in Patients with Coronary Artery Disease Undergoing Surgical Revascularization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SVC-CI
Brief Summary:
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 patients undergoing coronary artery bypass grafting surgery CABG and recording initial CO readings Based on CO the patients will be placed in study groups one or two Participants with normal and mildly reduced left ventricular ejection fraction LVEF gt40 for group one and those with moderately to severely reduced LVEF lt40 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
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
Detailed Description:
None
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