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

Phase 4

Terminated

• Conditions: Anesthesia
• Interventions: Drug: Open loop; Device: Closed-loop

• Registration Number: NCT01882075
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open loop	Open loop	fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
Closed-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.

Primary Outcome Measures

Name	Time	Method
Mean cardiac output index during the surgery	One day after anesthesia

Secondary Outcome Measures

Name	Time	Method
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
Time before reaching maximizing cardiac output	One day after anesthesia
Volume of fluid replacement during surgery	One day after anesthesia

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France