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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00610-43 | Other Identifier | ANSM |
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Dysfonction of the device
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The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.
The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.
We want to test if the closed-loop fluid administration is feasible.
Two groups will be compared. In all cases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open loop | Active Comparator | fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device |
|
| Closed-loop | Experimental | Fluid replacement is automated. An algorithm has been developed ; the input value is continuous cardiac output measured by LidCO rapid device; the computer steers iv infusion of hydroxyethyl starch 130/0.4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open loop | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean cardiac output index during the surgery | One day after anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Time before reaching maximizing cardiac output | One day after anesthesia | |
| Volume of fluid replacement during surgery | One day after anesthesia | |
| cardiac index during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92150 | France |
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| Closed-loop |
| Device |
|
|
Maximum and minimum values during the surgery |
| One day after anesthesia |
| arterial hypertension | Number of events treated | One day after anesthesia |
| Dysfunction of the closed-loop fluid device | One day after anesthesia |