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

Sponsor
Hopital Foch (Other)
Overall Status
Terminated
CT.gov ID
NCT01882075
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
18
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Open loop
  • Device: Closed-loop
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean cardiac output index during the surgery [One day after anesthesia]

    Secondary Outcome Measures

    1. Time before reaching maximizing cardiac output [One day after anesthesia]

    2. Volume of fluid replacement during surgery [One day after anesthesia]

    3. cardiac index during the surgery [One day after anesthesia]

      Maximum and minimum values during the surgery

    4. arterial hypertension [One day after anesthesia]

      Number of events treated

    5. Dysfunction of the closed-loop fluid device [One day after anesthesia]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Foch Suresnes France 92150

    Sponsors and Collaborators

    • Hopital Foch

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hopital Foch
    ClinicalTrials.gov Identifier:
    NCT01882075
    Other Study ID Numbers:
    • 2012/17
    • 2012-A00610-43
    First Posted:
    Jun 20, 2013
    Last Update Posted:
    Oct 31, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Hopital Foch
    Anesthesia
    Fluid administration
    Closed-loop
    Additional relevant MeSH terms:
    Hydroxyethyl Starch Derivatives

    Study Results

    No Results Posted as of Oct 31, 2016