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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Terminated; Phase 2

Conditions: Anesthesia

Treatments: Device: Learning Intravenous Resuscitator (LIR) system

Study type: Interventional

Funder types: Other

Identifiers

NCT02138942

2013-A01186-39 (Other Identifier)

AOI/2012/RC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

The study population

Experimental group

Description:

See inclusion/exclusion criteria. Intervention: LIR

Treatment:

Device: Learning Intravenous Resuscitator (LIR) system