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

Anesthesia Clinical Trial

— Closed Loop  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02138942
• Other study ID #: AOI/2012/RC-01
• Secondary ID: 2013-A01186-39
• Status: Terminated
• Phase: Phase 2
• First received: May 13, 2014
• Last updated: January 2, 2018
• Start date: November 17, 2014
• Est. completion date: October 20, 2015

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 20, 2015
• Est. primary completion date: September 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Saint-Eloi	Montpellier cedex 5
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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).; 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	The number of fluid administration modifications (cristalloid or colloid) performed by the device		Day 0, just after surgery
Secondary	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
Secondary	The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output		Day 0, just after surgery
Secondary	The total amount of crystalloid administered for basic inputs during surgery		Day 0, just after surgery
Secondary	The total amount of intravenous fluids administered during surgery		Day 0, just after surgery
Secondary	The mean cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
Secondary	The maximum cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
Secondary	The minimum cardiac output during surgery (liters of blood per minute)		Day 0, just after surgery
Secondary	Cardiac output at the end of surgery (liters of blood per minute)		Day 0, just after surgery
Secondary	The percent % variation in cardiac output during surgery		Day 0, just after surgery
Secondary	Mean blood pressure during surgery		Day 0, just after surgery
Secondary	Minimum blood pressure during surgery		Day 0, just after surgery
Secondary	Maximum blood pressure during surgery		Day 0, just after surgery
Secondary	% variation in blood pressure during surgery		Day 0, just after surgery
Secondary	Blood pressure at the end of surgery		Day 0, just after surgery
Secondary	The percentage of time during which the LIR system maintained an optimal/maximal cardiac output.	Maximizing cardiac output is defined as the cardiac output value for which a vascular filling (250 ml saline filling) causes less than 10% increase in stroke volume.	Day 0 (at the end of surgery)
Secondary	The minutes required to achieve maximized cardiac output.		Day 0 (at the end of surgery)
Secondary	The percentage of time spent in hypotension.		Day 0 (at the end of surgery)
Secondary	The number of hypotension and hypertension episodes requireing treatment.		Day 0 (just after surgery)
Secondary	Pulse pressure variation throughout surgery		Day 0 (just after surgery)
Secondary	Stroke volume throughout surgery		Day 0 (just after surgery)
Secondary	Stroke volume variation		Day 0 (just after surgery)
Secondary	Blood lactate		Day 0 (at the end of surgery)
Secondary	% oxygen saturation of central venous blood		Day 0 (at the end of surgery)
Secondary	Intraoperative urine output		Day 0 (at the end of surgery)
Secondary	The occurrence of postoperative complications defined by POSSUM criteria		Day 0 to 3; discharge from the post-intervention monitoring room
Secondary	Medical device malfunctions: presence/absence		Day 0 to 3; discharge from the post-intervention monitoring room
Secondary	Admission to ICU; yes/no		Day 0 to 3; discharge from the post-intervention monitoring room
Secondary	Length of stay in ICU		Day 0 to 3; discharge from the post-intervention monitoring room
Secondary	Length of hospital stay		Hospital discharge; expected maximum of 28 days
Secondary	The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool)		Hospital discharge; expected maximum of 28 days
Secondary	The period between the end of surgery and the recovery of a liquid diet		Hospital discharge; expected maximum of 28 days
Secondary	The period between the end of surgery and the resumption of solid food		Hospital discharge; expected maximum of 28 days
Secondary	The period between the end of surgery and the recovery of intestinal transit		Hospital discharge; expected maximum of 28 days
Secondary	Creatinemia		Baseline (day 0)
Secondary	Creatinemia		Day 1
Secondary	Creatinemia		Day 2
Secondary	Creatinemia		Day 5