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Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution (CONDUCT)

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ClinicalTrials.gov Identifier: NCT02728791
Recruitment Status : Unknown
Verified January 2018 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief Summary:
Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

Condition or disease
Shock Cardiac Output, Low

Detailed Description:

Since 2014, Edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. Initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. If this ClearSight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific ICU hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care.

This is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.
Actual Study Start Date : May 10, 2016
Estimated Primary Completion Date : December 10, 2018
Estimated Study Completion Date : December 10, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Comparison of values and changes in cardiac index between the two devices [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Comparison of values and variations in mean arterial pressure between the two devices [ Time Frame: 2 days ]
  2. Comparison of values and variations in mean cardiac output between the two devices [ Time Frame: 2 days ]
  3. Comparison of values and variations in mean stroke volume variation between the two devices [ Time Frame: 2 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults patients hospitalized in ICU with hemodynamic failure requiring vasoactive drugs
Criteria

Inclusion Criteria:

  • age>18
  • hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs
  • No opposition formulated

Exclusion Criteria:

  • Impossibility of establishment of one of the cardiac output measurement devices
  • Pregnant woman
  • Refuse to participate
Contacts and Locations
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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): NCT02728791


Contacts
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Contact: Jean-Ferréol JF OILLEAU 0298347961 ext +33 jean-ferreol.oilleau@chu-brest.fr
Contact: olivier O HUET 0298347288 ext +33 olivier.huet@chu-brest.fr

Locations
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France
CHRU BREST, Hôpital de la Cavale Blanche Recruiting
Brest, France, 29200
Contact: jean-ferréol JF OILLEAU    0298347961 ext +33    jean-ferreol.oilleau@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Olivier O HUET CHRU de Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02728791    
Other Study ID Numbers: CONDUCT (RB 15.144)
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases