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CompletedNCT01965574PRD-ARDS-PPUpdated Dec 19, 2025

Preload Dependence During Prone Position In ARDS Patients

An interventional study of Trendelenburg position in ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY

Keywords

  • ARDS - FLUID LOADING - PRELOAD DEPENDENCE
03

In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Age below 18
  • no affiliation to social security
  • Vena cava obstruction
  • previous inclusion in protocol
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Single arm

    Procedure: Trendelenburg position

Interventions

  • ProcedureTrendelenburg position
06

What researchers measure

Primary outcomes

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

    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%

    Time frame: 1 minute after Trendelenburg position onset.

Secondary outcomes

  1. Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence

    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%

    Time frame: 15 seconds after the onset of end-expiratory occlusion

  2. Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence

    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%

    Time frame: 1 minute after tidal volume increase to 8 ml/kg

07

Study locations

1 site
  • Hôpital de la Croix Rousse
    Lyon, 69004, France
08

References and documents

Publications

  • Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0. PubMed 29208025 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01965574
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Oct 18, 2013
Start date
Oct 2013
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Dec 19, 2025

Study contacts

Jean Christophe RICHARD
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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