NCT02020863

Closed-Loop Fluid Administration System Using Hemodynamic Monitors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Intraoperative Volume Status
• Postoperative Complications

Interventions

Type	Name	Description
DEVICE	Closed Loop	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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-12-25
• Last updated: 2016-05-27
• Results posted: 2016-05-27

Locations

1 site across 1 country: United States