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

Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01882075

Enrollment

Registered

2013-06-20

Start date

2013-06-30

Completion date

2014-12-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Fluid administration, Closed-loop

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.

Interventions

DRUGOpen loop

DEVICEClosed-loop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Mean cardiac output index during the surgery	One day after anesthesia

Secondary

Measure	Time frame	Description
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	One day after anesthesia	Maximum and minimum values during the surgery
arterial hypertension	One day after anesthesia	Number of events treated
Dysfunction of the closed-loop fluid device	One day after anesthesia	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026