Closed-Loop Fluid Administration System Using Hemodynamic Monitors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid administration system to deliver fluids using feedback from standard operating room hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the patient is determined by the anesthesiologist caring for the patient. In this study protocol, the rate of fluid administration will be determined instead by the closed-loop (automated) control system under the supervision of the anesthesiologist. The system will independently decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the system to ensure appropriate volumes are being delivered and to intervene if necessary.

Detailed Description
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In our protocol we will test the hypothesis that closed-loop fluid administration can maintain higher cardiac stroke volume (shown to improve patient outcomes after surgery) than anesthesiologist management. We have shown this to be the case in multiple simulation studies and in-vivo animal studies, but not yet experimentally in a clinical setting. Investigators will recruit their patients from the surgical record that that require cardiac output monitoring undergoing surgery and require mechanical ventilation and consent to participate in the study will be included in the study. They will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of fluid administration. Fluids are usually given to a patient based on the physician's discretion. As part of the study patients will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors at UCI). Data from this study will be retrospectively compared to subjects case matched to evaluate differences in cardiac output, total fluid given, and patient outcomes.

Official Title
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Closed-Loop Fluid Administration System Using Hemodynamic Monitors

Conditions
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Intraoperative Volume Status, Postoperative Complications

Intervention / Treatment
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* Device: Closed Loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (over the age of 18) Subjects undergoing elective major, abdominal surgery Subjects requiring general anesthesia and mechanical ventilation Subjects requiring cardiac output monitoring and an arterial line Exclusion Criteria: Subjects under 18 years of age Subjects not undergoing surgery Subjects not requiring general anesthesia or mechanical ventilation Subjects not requiring cardiac output monitoring or an arterial line Subjects who are pregnant Subjects without the capacity to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Loop<br>Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration. | Device: Closed Loop<br>* Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Status During Surgery | The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%. | Duration of Surgery, up to 8 hours |