Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01882075|
Recruitment Status : Terminated (Dysfonction of the device)
First Posted : June 20, 2013
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Open loop Device: Closed-loop||Phase 4|
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:
- anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
- cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Open loop
fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
Drug: Open loop
Other Name: fluid replacement by Voluven(hydroxyethyl starch 130/0.4)
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.
Other Name: fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop)
- Mean cardiac output index during the surgery [ Time Frame: One day after anesthesia ]
- Time before reaching maximizing cardiac output [ Time Frame: One day after anesthesia ]
- Volume of fluid replacement during surgery [ Time Frame: One day after anesthesia ]
- cardiac index during the surgery [ Time Frame: One day after anesthesia ]Maximum and minimum values during the surgery
- arterial hypertension [ Time Frame: One day after anesthesia ]Number of events treated
- Dysfunction of the closed-loop fluid device [ Time Frame: One day after anesthesia ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882075
|Suresnes, France, 92150|