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

• Conditions: Shock; Cardiac Output, Low

• Registration Number: NCT02728791
• Lead Sponsor: University Hospital, Brest

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).

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 Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Study Start: 2016-05-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24
• Primary Completion: 2018-12-10
• Study Completion: 2018-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of values and changes in cardiac index between the two devices	2 days

Secondary Outcome Measures

Name	Time	Method
Comparison of values and variations in mean arterial pressure between the two devices	2 days
Comparison of values and variations in mean stroke volume variation between the two devices	2 days
Comparison of values and variations in mean cardiac output between the two devices	2 days

Trial Locations

Locations (1)

CHRU BREST, Hôpital de la Cavale Blanche; 🇫🇷 Brest, France