Recruiting

Observational Study

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06645327

Conditions

Coronary Artery Bypass Grafting Surgery (CABG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

a change in operating room table position, which will mimic an IV fluid bolus

Study Details

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 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.

Conditions

Coronary Artery Bypass Grafting Surgery (CABG)

Study ID

NCT06645327

Start date

Feb 24, 2025

Status verified date

May, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18
2. Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
3. Participants who are able to consent for themselves
4. Primary language is English

Exclusion Criteria:

1. Age less than 18 years of age
2. Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)
3. Severe cardiac valvular pathologies or active congestive heart failure
4. Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.
5. Participants who are unable to consent for themselves
6. Primary language is something other than English

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

(LVEF>40%)

Group 2

(LVEF<40%),

Interventions

a change in operating room table position, which will mimic an IV fluid bolus

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

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 and Locations

Locations

Penn State Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-05-07.