Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
Overview
- Phase
- Phase 4
- Intervention
- Open loop
- Conditions
- Anesthesia
- Sponsor
- Hopital Foch
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Mean cardiac output index during the surgery
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients aged 18-75 years
- •Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
- •Consenting to participate in the study
Exclusion Criteria
- •Pregnant, breast feeding women
- •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
Arms & Interventions
Open loop
fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
Intervention: 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.
Intervention: Closed-loop
Outcomes
Primary Outcomes
Mean cardiac output index during the surgery
Time Frame: One day after anesthesia
Secondary Outcomes
- cardiac index during the surgery(One day after anesthesia)
- arterial hypertension(One day after anesthesia)
- Dysfunction of the closed-loop fluid device(One day after anesthesia)
- Time before reaching maximizing cardiac output(One day after anesthesia)
- Volume of fluid replacement during surgery(One day after anesthesia)