Clinical trial NCT02138942: Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia
Official title: Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anesthesia
Keywords: automated vascular filling
Learning Intravenous Resuscitator (LIR)
General Surgery
Fluid Therapy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.
timeFrame: Day 0, just after surgery
Secondary outcomes:
measure: The number of fluid administration modifications (cristalloid or colloid) performed by the device
timeFrame: Day 0, just after surgery
measure: The number of times the anesthetist in charge of the patient had to intervene with the fluid administration (cristalloid or colloid) system/device.
timeFrame: Day 0, just after surgery
measure: The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output
timeFrame: Day 0, just after surgery
measure: The total amount of crystalloid administered for basic inputs during surgery
timeFrame: Day 0, just after surgery
measure: The total amount of intravenous fluids administered during surgery
timeFrame: Day 0, just after surgery
measure: The mean cardiac output during surgery (liters of blood per minute)
timeFrame: Day 0, just after surgery
measure: The maximum cardiac output during surgery (liters of blood per minute)
timeFrame: Day 0, just after surgery
measure: The minimum cardiac output during surgery (liters of blood per minute)
timeFrame: Day 0, just after surgery
measure: Cardiac output at the end of surgery (liters of blood per minute)
timeFrame: Day 0, just after surgery
measure: The percent % variation in cardiac output during surgery
timeFrame: Day 0, just after surgery
measure: Mean blood pressure during surgery
timeFrame: Day 0, just after surgery
measure: Minimum blood pressure during surgery
timeFrame: Day 0, just after surgery
measure: Maximum blood pressure during surgery
timeFrame: Day 0, just after surgery
measure: % variation in blood pressure during surgery
timeFrame: Day 0, just after surgery
measure: Blood pressure at the end of surgery
timeFrame: Day 0, just after surgery
measure: The percentage of time during which the LIR system maintained an optimal/maximal cardiac output.
timeFrame: Day 0 (at the end of surgery)
measure: The minutes required to achieve maximized cardiac output.
timeFrame: Day 0 (at the end of surgery)
measure: The percentage of time spent in hypotension.
timeFrame: Day 0 (at the end of surgery)
measure: The number of hypotension and hypertension episodes requireing treatment.
timeFrame: Day 0 (just after surgery)
measure: Pulse pressure variation throughout surgery
timeFrame: Day 0 (just after surgery)
measure: Stroke volume throughout surgery
timeFrame: Day 0 (just after surgery)
measure: Stroke volume variation
timeFrame: Day 0 (just after surgery)
measure: Blood lactate
timeFrame: Day 0 (at the end of surgery)
measure: % oxygen saturation of central venous blood
timeFrame: Day 0 (at the end of surgery)
measure: Intraoperative urine output
timeFrame: Day 0 (at the end of surgery)
measure: The occurrence of postoperative complications defined by POSSUM criteria
timeFrame: Day 0 to 3; discharge from the post-intervention monitoring room
measure: Medical device malfunctions: presence/absence
timeFrame: Day 0 to 3; discharge from the post-intervention monitoring room
measure: Admission to ICU; yes/no
timeFrame: Day 0 to 3; discharge from the post-intervention monitoring room
measure: Length of stay in ICU
timeFrame: Day 0 to 3; discharge from the post-intervention monitoring room
measure: Length of hospital stay
timeFrame: Hospital discharge; expected maximum of 28 days
measure: The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool)
timeFrame: Hospital discharge; expected maximum of 28 days
measure: The period between the end of surgery and the recovery of a liquid diet
timeFrame: Hospital discharge; expected maximum of 28 days
measure: The period between the end of surgery and the resumption of solid food
timeFrame: Hospital discharge; expected maximum of 28 days
measure: The period between the end of surgery and the recovery of intestinal transit
timeFrame: Hospital discharge; expected maximum of 28 days
measure: Creatinemia
timeFrame: Baseline (day 0)
measure: Creatinemia
timeFrame: Day 1
measure: Creatinemia
timeFrame: Day 2
measure: Creatinemia
timeFrame: Day 5
Other outcomes:
Locations:
city: Montpellier cedex 5
country: France
facility: CHRU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Yves Lefrant, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire Roger, MD
role: PRINCIPAL_INVESTIGATOR
References: