Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position

Hospices Civils de Lyon1 site in 1 country33 target enrollmentOctober 1, 2013

ConditionsARDS PATIENTS WITH HEMODYNAMIC INSTABILITY

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY
Sponsor: Hospices Civils de Lyon
Enrollment: 33
Locations: 1
Primary Endpoint: Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.

Registry

clinicaltrials.gov

Start Date

October 1, 2013

End Date

January 1, 2017

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ARDS patient
•mechanically ventilated in prone position
•sedated and paralyzed
•with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis
•fluid loading as indicated by attending physician

Exclusion Criteria

•Age below 18
•no affiliation to social security
•Vena cava obstruction
•previous inclusion in protocol

Outcomes

Primary Outcomes

Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence

Time Frame: 1 minute after Trendelenburg position onset.

Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15%

Secondary Outcomes

Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence(1 minute after tidal volume increase to 8 ml/kg)
Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence(15 seconds after the onset of end-expiratory occlusion)