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

Phase 2

Terminated

• Conditions: Anesthesia
• Interventions: Device: Learning Intravenous Resuscitator (LIR) system

• Registration Number: NCT02138942
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Study Start: 2014-11-17
• Primary Completion: 2015-09-20
• Study Completion: 2015-10-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	Learning Intravenous Resuscitator (LIR) system	See inclusion/exclusion criteria. Intervention: LIR

Primary Outcome Measures

Name	Time	Method
The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.	Day 0, just after surgery	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

Secondary Outcome Measures

Name	Time	Method
Maximum blood pressure during surgery	Day 0, just after surgery
Stroke volume throughout surgery	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
Minimum blood pressure during surgery	Day 0, just after surgery
The total amount of intravenous fluids administered during surgery	Day 0, just after surgery
The total amount of crystalloid administered for basic inputs during surgery	Day 0, just after surgery
The mean 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
% 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 spent in hypotension.	Day 0 (at the end of surgery)
The number of fluid administration modifications (cristalloid or colloid) performed by the device	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
The minutes required to achieve maximized cardiac output.	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)
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
Mean blood pressure during surgery	Day 0, just after surgery
Stroke volume variation	Day 0 (just after surgery)
Admission to ICU; yes/no	Day 0 to 3; discharge from the post-intervention monitoring room
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 percentage of time during which the LIR system maintained an optimal/maximal cardiac output.	Day 0 (at the end of surgery)	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.
Blood lactate	Day 0 (at the end of surgery)
Length of hospital stay	Hospital discharge; expected maximum of 28 days
Creatinemia	Day 5
% oxygen saturation of central venous blood	Day 0 (at the end of surgery)
Intraoperative urine output	Day 0 (at the end of surgery)
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
Length of stay in ICU	Day 0 to 3; discharge from the post-intervention monitoring room
The period between the end of surgery and the recovery of intestinal transit	Hospital discharge; expected maximum of 28 days

Trial Locations

Locations (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CHRU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier cedex 5, France