NCT01965574CompletedNot Applicable
Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single arm
Experimental
Intervention: Trendelenburg position (Procedure)
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)
Investigators
Study Sites (1)
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