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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02728791
Other study ID # CONDUCT (RB 15.144)
Secondary ID
Status Recruiting
Phase N/A
First received March 25, 2016
Last updated January 23, 2018
Start date May 10, 2016
Est. completion date December 10, 2018

Study information

Verified date January 2018
Source University Hospital, Brest
Contact Jean-Ferréol JF OILLEAU
Phone 0298347961
Email jean-ferreol.oilleau@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 10, 2018
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU BREST, Hôpital de la Cavale Blanche Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of values and changes in cardiac index between the two devices 2 days
Secondary Comparison of values and variations in mean arterial pressure between the two devices 2 days
Secondary Comparison of values and variations in mean cardiac output between the two devices 2 days
Secondary Comparison of values and variations in mean stroke volume variation between the two devices 2 days
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