Preload Dependence During Prone Position In ARDS Patients

Not Applicable

Completed

• Conditions: ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY
• Interventions: Procedure: Trendelenburg position

• Registration Number: NCT01965574
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-18
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Trendelenburg position	-

Primary Outcome Measures

Name	Time	Method
Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence	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 Outcome Measures

Name	Time	Method
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	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%
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	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%

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France