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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01186-39 | Other Identifier | ANSM |
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non-compliance with the protocol. Arrest requested by the Monitoring Safety committee
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | See inclusion/exclusion criteria. Intervention: LIR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Learning Intravenous Resuscitator (LIR) system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 0, just after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The number of fluid administration modifications (cristalloid or colloid) performed by the device | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves Lefrant, MD, PhD | Centre Hospitalier Universitaire de NÄ«mes | Study Director |
| Claire Roger, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - HĂ´pital Saint-Eloi | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36143194 | Result | Gricourt Y, Prin Derre C, Demattei C, Bertran S, Louart B, Muller L, Simon N, Lefrant JY, Cuvillon P, Jaber S, Roger C. A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients. J Pers Med. 2022 Aug 30;12(9):1409. doi: 10.3390/jpm12091409. |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Day 0, just after surgery |
| The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output | Day 0, just after surgery |
| The total amount of crystalloid administered for basic inputs during surgery | Day 0, just after surgery |
| The total amount of intravenous fluids administered during surgery | Day 0, just after surgery |
| The mean cardiac output during surgery (liters of blood per minute) | Day 0, just after surgery |
| The maximum cardiac output during surgery (liters of blood per minute) | Day 0, just after surgery |
| The minimum cardiac output during surgery (liters of blood per minute) | Day 0, just after surgery |
| Cardiac output at the end of surgery (liters of blood per minute) | Day 0, just after surgery |
| The percent % variation in cardiac output during surgery | Day 0, just after surgery |
| Mean blood pressure during surgery | Day 0, just after surgery |
| Minimum blood pressure during surgery | Day 0, just after surgery |
| Maximum blood pressure during surgery | Day 0, just after surgery |
| % variation in blood pressure during surgery | Day 0, just after surgery |
| Blood pressure at the end of surgery | Day 0, just after surgery |
| 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) |
| The minutes required to achieve maximized cardiac output. | Day 0 (at the end of surgery) |
| The percentage of time spent in hypotension. | Day 0 (at the end of surgery) |
| The number of hypotension and hypertension episodes requireing treatment. | Day 0 (just after surgery) |
| Pulse pressure variation throughout surgery | Day 0 (just after surgery) |
| Stroke volume throughout surgery | Day 0 (just after surgery) |
| Stroke volume variation | Day 0 (just after surgery) |
| Blood lactate | Day 0 (at the end of surgery) |
| % oxygen saturation of central venous blood | Day 0 (at the end of surgery) |
| Intraoperative urine output | Day 0 (at the end of surgery) |
| The occurrence of postoperative complications defined by POSSUM criteria | Day 0 to 3; discharge from the post-intervention monitoring room |
| Medical device malfunctions: presence/absence | Day 0 to 3; discharge from the post-intervention monitoring room |
| Admission to ICU; yes/no | Day 0 to 3; discharge from the post-intervention monitoring room |
| Length of stay in ICU | Day 0 to 3; discharge from the post-intervention monitoring room |
| Length of hospital stay | Hospital discharge; expected maximum of 28 days |
| 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 |
| The period between the end of surgery and the recovery of a liquid diet | Hospital discharge; expected maximum of 28 days |
| The period between the end of surgery and the resumption of solid food | Hospital discharge; expected maximum of 28 days |
| The period between the end of surgery and the recovery of intestinal transit | Hospital discharge; expected maximum of 28 days |
| Creatinemia | Baseline (day 0) |
| Creatinemia | Day 1 |
| Creatinemia | Day 2 |
| Creatinemia | Day 5 |
| Nîmes |
| 30029 |
| France |