NCT02138942

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

Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	Learning Intravenous Resuscitator (LIR) system	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.

Timeline

• Start date: 2014-11-17
• Primary completion: 2016-12-28
• Completion: 2016-12-28
• First posted: 2014-05-15
• Last updated: 2025-11-17

Locations

2 sites across 1 country: France