Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia (Closed Loop)

• ClinicalTrials.gov Identifier: NCT02138942
• Recruitment Status: Terminated
• First Posted: May 15, 2014
• Last Update Posted: January 3, 2018
• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nīmes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Device: Learning Intravenous Resuscitator (LIR) system	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study
• Actual Study Start Date: November 17, 2014
• Actual Primary Completion Date: September 20, 2015
• Actual Study Completion Date: October 20, 2015

Arms and Interventions

Arm

Intervention/treatment

Experimental: The study population; See inclusion/exclusion criteria. Intervention: LIR

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

   A change may be non-validated in the following two situations:

   1. 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).

   2. 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

Secondary Outcome Measures :

1. The number of fluid administration modifications (cristalloid or colloid) performed by the device [ Time Frame: Day 0, just after surgery ]
2. 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 ]
3. The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output [ Time Frame: Day 0, just after surgery ]
4. The total amount of crystalloid administered for basic inputs during surgery [ Time Frame: Day 0, just after surgery ]
5. The total amount of intravenous fluids administered during surgery [ Time Frame: Day 0, just after surgery ]
6. The mean cardiac output during surgery (liters of blood per minute) [ Time Frame: Day 0, just after surgery ]
7. The maximum cardiac output during surgery (liters of blood per minute) [ Time Frame: Day 0, just after surgery ]
8. The minimum cardiac output during surgery (liters of blood per minute) [ Time Frame: Day 0, just after surgery ]
9. Cardiac output at the end of surgery (liters of blood per minute) [ Time Frame: Day 0, just after surgery ]
10. The percent % variation in cardiac output during surgery [ Time Frame: Day 0, just after surgery ]
11. Mean blood pressure during surgery [ Time Frame: Day 0, just after surgery ]
12. Minimum blood pressure during surgery [ Time Frame: Day 0, just after surgery ]
13. Maximum blood pressure during surgery [ Time Frame: Day 0, just after surgery ]
14. % variation in blood pressure during surgery [ Time Frame: Day 0, just after surgery ]
15. Blood pressure at the end of surgery [ Time Frame: Day 0, just after surgery ]
16. The percentage of time during which the LIR system maintained an optimal/maximal cardiac output. [ Time Frame: Day 0 (at the end of surgery) ]
    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.
17. The minutes required to achieve maximized cardiac output. [ Time Frame: Day 0 (at the end of surgery) ]
18. The percentage of time spent in hypotension. [ Time Frame: Day 0 (at the end of surgery) ]
19. The number of hypotension and hypertension episodes requireing treatment. [ Time Frame: Day 0 (just after surgery) ]
20. Pulse pressure variation throughout surgery [ Time Frame: Day 0 (just after surgery) ]
21. Stroke volume throughout surgery [ Time Frame: Day 0 (just after surgery) ]
22. Stroke volume variation [ Time Frame: Day 0 (just after surgery) ]
23. Blood lactate [ Time Frame: Day 0 (at the end of surgery) ]
24. % oxygen saturation of central venous blood [ Time Frame: Day 0 (at the end of surgery) ]
25. Intraoperative urine output [ Time Frame: Day 0 (at the end of surgery) ]
26. The occurrence of postoperative complications defined by POSSUM criteria [ Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room ]
27. Medical device malfunctions: presence/absence [ Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room ]
28. Admission to ICU; yes/no [ Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room ]
29. Length of stay in ICU [ Time Frame: Day 0 to 3; discharge from the post-intervention monitoring room ]
30. Length of hospital stay [ Time Frame: Hospital discharge; expected maximum of 28 days ]
31. 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 ]
32. The period between the end of surgery and the recovery of a liquid diet [ Time Frame: Hospital discharge; expected maximum of 28 days ]
33. The period between the end of surgery and the resumption of solid food [ Time Frame: Hospital discharge; expected maximum of 28 days ]
34. The period between the end of surgery and the recovery of intestinal transit [ Time Frame: Hospital discharge; expected maximum of 28 days ]
35. Creatinemia [ Time Frame: Baseline (day 0) ]
36. Creatinemia [ Time Frame: Day 1 ]
37. Creatinemia [ Time Frame: Day 2 ]
38. Creatinemia [ Time Frame: Day 5 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier cedex 5, France, 34295

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes Cedex 9, France, 30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

• Study Director: Jean-Yves Lefrant, MD, PhD; Centre Hospitalier Universitaire de Nîmes
• Principal Investigator: Claire Roger, MD; Centre Hospitalier Universitaire de Nîmes

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT02138942
• Other Study ID Numbers: AOI/2012/RC-01; 2013-A01186-39 ( Other Identifier: RCB number )
• First Posted: May 15, 2014
• Last Update Posted: January 3, 2018
• Last Verified: January 2018

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

automated vascular filling; Learning Intravenous Resuscitator (LIR); General Surgery; Fluid Therapy