N/A
N=40
Closed-Loop Fluid Administration System Using Hemodynamic Monitors
Intraoperative Volume Status · Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT02020863 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Fluid Status During Surgery — 95 percentage of case time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Closed Loop (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluid Status During Surgery |
95 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02020863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.