Colorectal Surgery, Hepatectomy, Major Abdominal Surgery, Pancreatectomy, Pancreaticoduodenectomy
Conditions
Keywords
anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery
Brief summary
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
Interventions
DEVICEClosed loop automated System (LIR®: learning intravenous resuscitator)
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.
DEVICEmanual current practice by anesthesiologist team
The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.
Sponsors
University of California, Irvine
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective major abdominal surgery * Patient physical status ASA 2-4 * General anesthesia with positive pressure ventilation * High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori.
Exclusion criteria
* Pregnant female * Intraoperative hyperthermic chemotherapy procedure * Patient physical status ASA more than 4 * Patient with allergy to hydroxyethyl starch * Cardiac arrhythmia * ventilation with tidal volume inferior 7mL/Kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean indexed cardiac output | J1 to J12 (Within the surgical hospital length of stay) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| per operative hemodynamic parameter | J1 (per operative time) | — |
| Per operative fluid administration | J1 (per operative) | — |
| Hospital length of stay | J1 to J12 | Within the surgical hospital length of stay |
| Occurrence of a adverse event after surgery | an expected average of 12 days | Within the surgical hospital length of stay |
| Occurrence of a death whatever the cause | an expected average of 12 days | Within the surgical hospital length of stay |
Countries
France
Outcome results
None listed