Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility
NCT ID: NCT01882075
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2013-06-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Open loop
fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
Open loop
Closed-loop
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.
Closed-loop
Interventions
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Open loop
Closed-loop
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
* Consenting to participate in the study
Exclusion Criteria
* Allergy
* Pacemaker
* Psychiatric disease, dementia, brain disease
* Contraindication to hydroxyethyl starch
* Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume \< 7 ml/Kg
18 Years
75 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Locations
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Hopital Foch
Suresnes, , France
Countries
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Other Identifiers
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2012-A00610-43
Identifier Type: OTHER
Identifier Source: secondary_id
2012/17
Identifier Type: -
Identifier Source: org_study_id