SSVC-CI During CABG

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Participants with CAD undergoing CABG utilizing cardiopulmonary bypass

Participants who are able to consent for themselves

Primary language is English

Disqualifiers

Age less than 18 years of age

Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)

Severe cardiac valvular pathologies or active congestive heart failure

Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.

Trial population

Participants with CAD undergoing CABG utilizing cardiopulmonary bypass

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

Primary outcomes

1

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.

1. Responders increases by 12% or more following intervention 2. Non responders less than 12% change in CO following intervention.

Time frame
10 minutes of time added to your surgery time.

Secondary outcomes

Other outcomes

Sponsors and contacts

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