Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Anesthesia

Treatments: Drug: Open loop; Device: Closed-loop

Study type: Interventional

Funder types: Other

Identifiers

NCT01882075

2012/17

2012-A00610-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Open loop

Active Comparator group

Description:

fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device

Treatment:

Drug: Open loop

Closed-loop

Experimental group

Description:

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.

Treatment:

Device: Closed-loop