Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882075
Recruitment Status : Terminated (Dysfonction of the device)
First Posted : June 20, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop)




Primary Outcome Measures :
  1. Mean cardiac output index during the surgery [ Time Frame: One day after anesthesia ]

Secondary Outcome Measures :
  1. Time before reaching maximizing cardiac output [ Time Frame: One day after anesthesia ]
  2. Volume of fluid replacement during surgery [ Time Frame: One day after anesthesia ]
  3. cardiac index during the surgery [ Time Frame: One day after anesthesia ]
    Maximum and minimum values during the surgery

  4. arterial hypertension [ Time Frame: One day after anesthesia ]
    Number of events treated

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882075


Locations
Layout table for location information
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Layout table for additonal information
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01882075    
Other Study ID Numbers: 2012/17
2012-A00610-43 ( Other Identifier: ANSM )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by Hopital Foch:
Anesthesia
Fluid administration
Closed-loop
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes