Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia

Phase 2TerminatedNCT02138942

Centre Hospitalier Universitaire de Nīmes30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anesthesia

Interventions

Learning Intravenous Resuscitator (LIR) systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

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: 1. Stopping criteria when using the LIR system: * malfunction of the device * malfunction 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). 2. 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/no * The prediction parameter for filling response (pulse pressure variation) indicates vascular filling? yes/no