Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia (Closed Loop)

Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study

The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Device: Learning Intravenous Resuscitator (LIR) system

Detailed Description

This is a prospective, bi-center, open "Phase II" type study on a medical device (the LIR system). It is the first trial of the device on humans.

The study, which begins at the signing of consent (made the day before or the day of surgery), ends when the patient leaves the hospital. The LIR system is used on a small population of patients under general anesthesia for the automated administration of intravenous fluids during major abdominal surgery by laparotomy or laparoscopy. Several criteria describing the fluids administered, cardiac output, blood pressure and other parameters will be identified during surgery.

This Phase II study is carried out in two, subsequent stages of size "n1" = 19 and "n" = 42.

Strengthening of security :

• The device will be used under the direct supervision of an anesthesiologist ; he / she can regain control instantly when needed .
• An independent oversight committee will be formed and consulted every 10 patients.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Saint-Eloi
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient will receive general anesthesia for a surgical procedure with the following characteristics: ----- planned abdominal surgery by laparotomy or laparoscopy with a probable duration> 2 hours ----- invasive monitoring of blood pressure ----- administration of crystalloid and colloid (HEA PM <150 kDa)

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient has a contraindication for a treatment used in this study: ----- Contraindications to the administration of HES MW <150 kDa ----- Patient classified NYHA> 2 ----- Allergy to HEA
• The patient has a pacemaker
• Surgery with cardiopulmonary bypass
• Surgery on the skull
• Dementia
• Patients with brain pathology (tumor, stroke, Parkinson's disease, ...)
• Patients with a psychiatric disorder, severe depression or psychosis, as well as those receiving antipsychotic treatment
• Limitations concerning the use of respiratory pulse pressure variation: cardiac arrhythmia, spontaneous ventilation, using a volume flow <7 ml / kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The study population; See inclusion/exclusion criteria. Intervention: LIR

Device: Learning Intravenous Resuscitator (LIR) system; The usual patient pathways and recommendations concerning vascular filling remain strictly unchanged in this study. The only thing that differs from usual care is the use of the LIR system to automatically optimize fluid resuscitation during general anesthesia, with continuous supervision by the anesthesiologist present during the entire period of use of the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.	A change may be non-validated in the following two situations: Stopping criteria when using the LIR system:malfunction of the devicemalfunction of the electric syringe (Agilia, Fresenius Kabi, Germany)an abnormality of cardiac output measurement or appearance of a limitation to the use of pulse pressure variation (cardiac arrhythmia, spontaneous ventilation, tidal volume <7 ml / kg of theoretical ideal weight).; Non-validation criteria for fluid administration despite a positive indication by the LIR device: If the answer to the two following questions are both yes, preventing the LIR device from acting is not theoretically justified, and the anesthesiologist must justify stopping the device and record the reason for his/her non-validation of the administration of fluid therapy.The last fill increased cardiac output more than 15%? yes/noThe prediction parameter for filling response (pulse pressure variation) indicates vascular filling? yes/no	Day 0, just after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of fluid administration modifications (cristalloid or colloid) performed by the device		Day 0, just after surgery
The number of times the anesthetist in charge of the patient had to intervene with the fluid administration (cristalloid or colloid) system/device.		Day 0, just after surgery
The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output		Day 0, just after surgery
The total amount of crystalloid administered for basic inputs during surgery		Day 0, just after surgery
The total amount of intravenous fluids administered during surgery		Day 0, just after surgery
The mean cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
The maximum cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
The minimum cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
Cardiac output at the end of surgery (liters of blood per minute)		Day 0, just after surgery
The percent % variation in cardiac output during surgery		Day 0, just after surgery
Mean blood pressure during surgery		Day 0, just after surgery
Minimum blood pressure during surgery		Day 0, just after surgery
Maximum blood pressure during surgery		Day 0, just after surgery
% variation in blood pressure during surgery		Day 0, just after surgery
Blood pressure at the end of surgery		Day 0, just after surgery
The percentage of time during which the LIR system maintained an optimal/maximal cardiac output.	Maximizing cardiac output is defined as the cardiac output value for which a vascular filling (250 ml saline filling) causes less than 10% increase in stroke volume.	Day 0 (at the end of surgery)
The minutes required to achieve maximized cardiac output.		Day 0 (at the end of surgery)
The percentage of time spent in hypotension.		Day 0 (at the end of surgery)
The number of hypotension and hypertension episodes requireing treatment.		Day 0 (just after surgery)
Pulse pressure variation throughout surgery		Day 0 (just after surgery)
Stroke volume throughout surgery		Day 0 (just after surgery)
Stroke volume variation		Day 0 (just after surgery)
Blood lactate		Day 0 (at the end of surgery)
% oxygen saturation of central venous blood		Day 0 (at the end of surgery)
Intraoperative urine output		Day 0 (at the end of surgery)
The occurrence of postoperative complications defined by POSSUM criteria		Day 0 to 3; discharge from the post-intervention monitoring room
Medical device malfunctions: presence/absence		Day 0 to 3; discharge from the post-intervention monitoring room
Admission to ICU; yes/no		Day 0 to 3; discharge from the post-intervention monitoring room
Length of stay in ICU		Day 0 to 3; discharge from the post-intervention monitoring room
Length of hospital stay		Hospital discharge; expected maximum of 28 days
The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool)		Hospital discharge; expected maximum of 28 days
The period between the end of surgery and the recovery of a liquid diet		Hospital discharge; expected maximum of 28 days
The period between the end of surgery and the resumption of solid food		Hospital discharge; expected maximum of 28 days
The period between the end of surgery and the recovery of intestinal transit		Hospital discharge; expected maximum of 28 days
Creatinemia		Baseline (day 0)
Creatinemia		Day 1
Creatinemia		Day 2
Creatinemia		Day 5

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Jean-Yves Lefrant, MD, PhD, Centre Hospitalier Universitaire de Nīmes; Principal Investigator: Claire Roger, MD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Gricourt Y, Prin Derre C, Demattei C, Bertran S, Louart B, Muller L, Simon N, Lefrant JY, Cuvillon P, Jaber S, Roger C. A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients. J Pers Med. 2022 Aug 30;12(9):1409. doi: 10.3390/jpm12091409.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2014
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimated): May 15, 2014

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: General Surgery; Fluid Therapy; automated vascular filling; Learning Intravenous Resuscitator (LIR)
• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: AOI/2012/RC-01; 2013-A01186-39 (Other Identifier: ANSM)