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

NCT02138942 | Terminated Phase 2 DMC

• 2 other identifiers: AOI/2012/RC-012013-A01186-39
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia

Keywords

automated vascular filling; Learning Intravenous Resuscitator (LIR); General Surgery; Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0, just after surgery

Secondary Outcomes (38)

• 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

Study Arms (1)

The study population

EXPERIMENTAL

See inclusion/exclusion criteria. Intervention: LIR

Device: Learning Intravenous Resuscitator (LIR) system

Interventions

Learning Intravenous Resuscitator (LIR) system DEVICE

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.

The study population

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 36143194 RESULT

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jean-Yves Lefrant, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Claire Roger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: November 17, 2014
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: November 17, 2025

Record last verified: 2018-01

Locations

FR (2)