Anesthesia Clinical Trial
Official title:
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.
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.
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