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

October 28, 2016 updated by: Hopital Foch

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Open loop
fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
Drug: Open loop
Other Names:
  • fluid replacement by Voluven(hydroxyethyl starch 130/0.4)
EXPERIMENTAL: 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.
Device: Closed-loop
Other Names:
  • fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean cardiac output index during the surgery
Time Frame: One day after anesthesia
One day after anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time before reaching maximizing cardiac output
Time Frame: One day after anesthesia
One day after anesthesia
Volume of fluid replacement during surgery
Time Frame: One day after anesthesia
One day after anesthesia
cardiac index during the surgery
Time Frame: One day after anesthesia
Maximum and minimum values during the surgery
One day after anesthesia
arterial hypertension
Time Frame: One day after anesthesia
Number of events treated
One day after anesthesia
Dysfunction of the closed-loop fluid device
Time Frame: One day after anesthesia
One day after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (ESTIMATE)

June 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/17
  • 2012-A00610-43 (OTHER: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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