Closed-Loop Fluid Administration System Using Hemodynamic Monitors

NCT02020863 | Completed Results DMC

• 1 other identifier: UCIANES03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraoperative Volume Status; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Closed Loop

EXPERIMENTAL

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

Interventions

Closed Loop DEVICE

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.

Closed Loop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92858, United States

Location

Related Publications (15)

• Rinehart J, Liu N, Alexander B, Cannesson M. Review article: closed-loop systems in anesthesia: is there a potential for closed-loop fluid management and hemodynamic optimization? Anesth Analg. 2012 Jan;114(1):130-43. doi: 10.1213/ANE.0b013e318230e9e0. Epub 2011 Sep 29.

  PMID: 21965362 BACKGROUND

• Bednarski P, Siclari F, Voigt A, Demertzis S, Lau G. Use of a computerized closed-loop sodium nitroprusside titration system for antihypertensive treatment after open heart surgery. Crit Care Med. 1990 Oct;18(10):1061-5. doi: 10.1097/00003246-199010000-00002.

  PMID: 2209031 BACKGROUND

• Colvin JR, Kenny GN. Development and evaluation of a dual-pump microcomputer-based closed-loop arterial pressure control system. Int J Clin Monit Comput. 1989 Jan;6(1):31-5. doi: 10.1007/BF01723370.

  PMID: 2723513 BACKGROUND

• Blankenship HB, Wallace FD, Pacifico AD. Clinical application of closed-loop postoperative autotransfusion. Med Prog Technol. 1990 May;16(1-2):89-93.

  PMID: 2138701 BACKGROUND

• Bowman RJ, Westenskow DR. A microcomputer-based fluid infusion system for the resuscitation of burn patients. IEEE Trans Biomed Eng. 1981 Jun;28(6):475-9. doi: 10.1109/TBME.1981.324822. No abstract available.

  PMID: 7287047 BACKGROUND

• Chaisson NF, Kirschner RA, Deyo DJ, Lopez JA, Prough DS, Kramer GC. Near-infrared spectroscopy-guided closed-loop resuscitation of hemorrhage. J Trauma. 2003 May;54(5 Suppl):S183-92. doi: 10.1097/01.TA.0000064508.11512.28.

  PMID: 12768123 BACKGROUND

• DeBey RK, Westenskow DR, Jordan WS, McJames SW. A urine based control system for fluid infusion. Biomed Sci Instrum. 1987;23:195-8. No abstract available.

  PMID: 3607171 BACKGROUND

• Rinehart J, Alexander B, Le Manach Y, Hofer C, Tavernier B, Kain ZN, Cannesson M. Evaluation of a novel closed-loop fluid-administration system based on dynamic predictors of fluid responsiveness: an in silico simulation study. Crit Care. 2011;15(6):R278. doi: 10.1186/cc10562. Epub 2011 Nov 23.

  PMID: 22112587 BACKGROUND

• Rinehart J, Lee C, Cannesson M, Dumont G. Closed-loop fluid resuscitation: robustness against weight and cardiac contractility variations. Anesth Analg. 2013 Nov;117(5):1110-8. doi: 10.1213/ANE.0b013e3182930050.

  PMID: 23835454 BACKGROUND

• Rinehart J, Lee C, Canales C, Kong A, Kain Z, Cannesson M. Closed-loop fluid administration compared to anesthesiologist management for hemodynamic optimization and resuscitation during surgery: an in vivo study. Anesth Analg. 2013 Nov;117(5):1119-29. doi: 10.1213/ANE.0b013e3182937d61.

  PMID: 23835453 BACKGROUND

• Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.

  PMID: 16356219 BACKGROUND

• Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

  PMID: 20705785 BACKGROUND

• Rinehart J, Chung E, Canales C, Cannesson M. Intraoperative stroke volume optimization using stroke volume, arterial pressure, and heart rate: closed-loop (learning intravenous resuscitator) versus anesthesiologists. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):933-9. doi: 10.1053/j.jvca.2012.05.015. Epub 2012 Jul 12.

  PMID: 22795172 BACKGROUND

• Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.

  PMID: 25888403 DERIVED

• Joosten A, Huynh T, Suehiro K, Canales C, Cannesson M, Rinehart J. Goal-Directed fluid therapy with closed-loop assistance during moderate risk surgery using noninvasive cardiac output monitoring: A pilot study. Br J Anaesth. 2015 Jun;114(6):886-92. doi: 10.1093/bja/aev002. Epub 2015 Feb 17.

  PMID: 25690834 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Maxime Cannesson, PhD
• Organization: University of California, Irvine Health

mcanness@uci.edu

714- 456-5059

Study Officials

• Maxime Cannesson, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 27, 2016
• Results First Posted: May 27, 2016

Record last verified: 2016-04

Locations

US (1)