Preload Dependence During Prone Position In ARDS Patients (PRD-ARDS-PP)

December 13, 2025 updated by: Hospices Civils de Lyon

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Procedure: Trendelenburg position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
1 minute after Trendelenburg position onset.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean Christophe RICHARD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimated)

October 18, 2013

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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