SSVC-CI During CABG

Conditions

• Coronary Artery Bypass Grafting Surgery (CABG)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 1. the participant will be placed in the reverse Trendelenburg position (head up) to 15 degrees for 60-90 seconds. CO measurement will be obtained 2. the participant will be transitioned to the Trendelenburg position (head down) to 15 degrees for 60-90 seconds. CO measurement will be obtained

Study Details

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.

Key Dates

Start date

Feb 24, 2025

Status verified

May 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Group 1
  (LVEF\>40%)
• Arm: Group 2
  (LVEF\<40%),

Primary Outcome Measure

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. [ Time Frame: 10 minutes of time added to your surgery time. ]

Central Contacts

• Edward Stredny, MD
  717-531-8521
  [email protected]
• Cynthia Reed, BS
  717-531-0003
  [email protected]

Locations (1)

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