Closed-Loop Fluid Administration System Using Hemodynamic Monitors
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | November 2012 |
| End Date: | June 2014 |
| Contact: | Maxime Cannesson, MD, PhD |
| Email: | mcanness@uci.edu |
| Phone: | (714) 456-8869 |
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.
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.
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.
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.
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
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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