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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02138942
Date of registration:	13/05/2014
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia Closed Loop
Scientific title:	Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study
Date of first enrolment:	November 17, 2014
Target sample size:	30
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02138942
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 2

Countries of recruitment
France

Contacts

Name:	Claire Roger, MD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Name:	Jean-Yves Lefrant, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia

Intervention(s)

Device: Learning Intravenous Resuscitator (LIR) system

Primary Outcome(s)

The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist. [Time Frame: Day 0, just after surgery]

Secondary Outcome(s)

Cardiac output at the end of surgery (liters of blood per minute) [Time Frame: Day 0, just after surgery]

Creatinemia [Time Frame: Baseline (day 0)]

The maximum cardiac output during surgery (liters of blood per minute) [Time Frame: Day 0, just after surgery]

The occurrence of postoperative complications defined by POSSUM criteria [Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room]

The period between the end of surgery and the resumption of solid food [Time Frame: Hospital discharge; expected maximum of 28 days]

Medical device malfunctions: presence/absence [Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room]

Pulse pressure variation throughout surgery [Time Frame: Day 0 (just after surgery)]

Stroke volume variation [Time Frame: Day 0 (just after surgery)]

Length of hospital stay [Time Frame: Hospital discharge; expected maximum of 28 days]

The percent % variation in cardiac output during surgery [Time Frame: Day 0, just after surgery]

The mean cardiac output during surgery (liters of blood per minute) [Time Frame: Day 0, just after surgery]

The number of hypotension and hypertension episodes requireing treatment. [Time Frame: Day 0 (just after surgery)]

The period between the end of surgery and the recovery of intestinal transit [Time Frame: Hospital discharge; expected maximum of 28 days]

% variation in blood pressure during surgery [Time Frame: Day 0, just after surgery]

Intraoperative urine output [Time Frame: Day 0 (at the end of surgery)]

Length of stay in ICU [Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room]

Stroke volume throughout surgery [Time Frame: Day 0 (just after surgery)]

% oxygen saturation of central venous blood [Time Frame: Day 0 (at the end of surgery)]

Admission to ICU; yes/no [Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room]

Mean blood pressure during surgery [Time Frame: Day 0, just after surgery]

Minimum blood pressure during surgery [Time Frame: Day 0, just after surgery]

Blood lactate [Time Frame: Day 0 (at the end of surgery)]

Blood pressure at the end of surgery [Time Frame: Day 0, just after surgery]

The total amount of intravenous fluids administered during surgery [Time Frame: Day 0, just after surgery]

Creatinemia [Time Frame: Day 1]

Creatinemia [Time Frame: Day 2]

Creatinemia [Time Frame: Day 5]

The minimum cardiac output during surgery (liters of blood per minute) [Time Frame: Day 0, just after surgery]

The number of fluid administration modifications (cristalloid or colloid) performed by the device [Time Frame: Day 0, just after surgery]

The minutes required to achieve maximized cardiac output. [Time Frame: Day 0 (at the end of surgery)]

The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool) [Time Frame: Hospital discharge; expected maximum of 28 days]

The percentage of time during which the LIR system maintained an optimal/maximal cardiac output. [Time Frame: Day 0 (at the end of surgery)]

The total amount of crystalloid administered for basic inputs during surgery [Time Frame: Day 0, just after surgery]

The number of times the anesthetist in charge of the patient had to intervene with the fluid administration (cristalloid or colloid) system/device. [Time Frame: Day 0, just after surgery]

The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output [Time Frame: Day 0, just after surgery]

The percentage of time spent in hypotension. [Time Frame: Day 0 (at the end of surgery)]

Maximum blood pressure during surgery [Time Frame: Day 0, just after surgery]

The period between the end of surgery and the recovery of a liquid diet [Time Frame: Hospital discharge; expected maximum of 28 days]

Secondary ID(s)

AOI/2012/RC-01

2013-A01186-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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