Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization

NCT ID: NCT06645327

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2029-01-31

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 Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

(LVEF\>40%)

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

Intervention Type: 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

Group 2

(LVEF\<40%),

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

Intervention Type: 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

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Edward Stredny, MD

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward Stredny, MD

Role: CONTACT

estredny@pennstatehealth.psu.edu

717-531-8521

Cynthia Reed, BS

Role: CONTACT

creed@pennstatehealth.psu.edu

717-531-0003 ext. 282465

References

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.

Reference Type: BACKGROUND

Other Identifiers

Study 24328

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY 24328

Identifier Type: -

Identifier Source: org_study_id