Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated fluid management system (Closed-loop system) | Experimental | cardiac output Vigileo® (Edwards Lifesciences) monitoring is connected to the closed loop system that will automatically provide per operative fluid bolus to optimize cardiac output by automated detection of fluid responsiveness state. |
|
| Current practice manual fluid management | Sham Comparator | cardiac output Vigileo® (Edwards Lifesciences) monitoring will be used to help the anesthesiologist team to detect fluid responsiveness state for the manual fluid management optimization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed loop automated System (LIR®: learning intravenous resuscitator) | Device | Connection of the system to the patient under supervision of the anesthesiologist team during all the anesthesia procedure, respective of the applicability criteria for the fluid responsiveness detection. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean indexed cardiac output | J1 to J12 (Within the surgical hospital length of stay) |
| Measure | Description | Time Frame |
|---|---|---|
| per operative hemodynamic parameter | J1 (per operative time) | |
| Per operative fluid administration | J1 (per operative) | |
| Hospital length of stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69 495 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29380190 | Background | Lilot M, Bellon A, Gueugnon M, Laplace MC, Baffeleuf B, Hacquard P, Barthomeuf F, Parent C, Tran T, Soubirou JL, Robinson P, Bouvet L, Vassal O, Lehot JJ, Piriou V. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial. J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| manual current practice by anesthesiologist team | Device | The anesthesiologist team will manage the fluid administration during all the anesthesia procedure. |
|
Within the surgical hospital length of stay |
| J1 to J12 |
| Occurrence of a adverse event after surgery | Within the surgical hospital length of stay | an expected average of 12 days |
| Occurrence of a death whatever the cause | Within the surgical hospital length of stay | an expected average of 12 days |