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

Shock Clinical Trial

— CONDUCT  

Official title:

Comparaison de Mesure de débit Cardiaque Entre système Clearsight® et Thermodilution Transpulmonaire.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728791
• Other study ID #: CONDUCT (RB 15.144)
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Shock

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