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Fluid Responsiveness Prediction During Prone Position (PROLOAD)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trendelenburg maneuver
End-expiratory occlusion test (EE OCC)
End-expiratory and end-inspiratory occlusion test (EI OCC)
Tidal volume challenge
Fluid bolus (reference diagnostic method)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, Fluid responsiveness, Fluid resuscitation, Cardiac output, Cardiac preload, Prone position, Continuous cardiac output monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patient (including patient under protective measures/wardship) with ARDS as defined by the Berlin criteria in the prone position as per international guidelines with a calibrated continuous cardiac output monitoring device with a clinical indication for a fluid bolus as prescribed by the clinician in charge, and fulfilling at least 2 clinical criteria: mottles, tachycardia, hypotension, drop in cardiac output, oliguria, high arterial lactate concentration, or any other detailed criterion with no respiratory efforts Exclusion Criteria: acute cor pulmonale patient treated with veno-venous extra-corporeal membrane oxygenation hemorrhagic shock Child-Pugh C cirrhosis death expected to occur in less than 24h decision to withhold or suspend active treatments intracranial hypertension lower limb amputation obstruction of the inferior vena cava acute abdominal syndrome absence of consent to participate pregnancy patient previously enrolled in the same study lack of affiliation to a social security regimen, as per French legislation patient deprived of its liberty

Sites / Locations

  • CHU Gabriel Montpied
  • Hôpital de la Croix Rousse, Hospices Civils de LyonRecruiting
  • CHU de Nice - l'Archet 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge

Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC

Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC

Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC

Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC

Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge

EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver

EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge

EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC

EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver

EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC

EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge

EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver

EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC

EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge

EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC

EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge

EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver

Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver

Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC

Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC

Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC

Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC

Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver

Arm Description

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence

Outcomes

Primary Outcome Measures

Area under the ROC curve (AUROC) of the evaluated tests.
The AUROC will be determined for each of the 4 clinical tests evaluated in this study. The reference method to define the AUROC to design the curve will be the fluid responsive status (responder vs. non-responder) as determined by the fluid bolus. For each test, the AUROC will be accompanied with its 95% confidence interval.

Secondary Outcome Measures

Comparison of diagnostic performance of the evaluated tests.
For this outcome measure, the AUROCs will be determined as for the primary outcome measure. The AUROCs will be compared using the Delong's method, with adjustments for the repetition of measurements in a single patient.
Diagnostic performance metrics of each test
Sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the evaluated tests, computed for the optimal diagnostic threshold determined using the Youden J index of the ROC curve. The optimal threshold will only be computed for AUROCs significantly different from 0.5.
Weighted diagnostic performance of each test
Sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the evaluated tests, computed for the optimal diagnostic threshold determined using the Youden J index of the ROC curve, and adjusted using weighting based on the clinical tradeoff of the subsequent fluid bolus on hemodynamic benefit vs. the respiratory risk. The optimal threshold will only be computed for AUROCs significantly different from 0.5.
Grey zone area of the optimal diagnostic threshold of each test
Determination of the boundaries of a grey zone around the value of the optimal threshold of each test, in which the diagnostic performance is deemed clinically insufficient (excessive misclassification risk due to lack of discrimination). The grey zone around the optimal threshold will only be computed for AUROCs significantly different from 0.5.

Full Information

First Posted
June 1, 2023
Last Updated
October 9, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05898269
Brief Title
Fluid Responsiveness Prediction During Prone Position
Acronym
PROLOAD
Official Title
Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Predicting fluid responsiveness is primordial when caring for patients with circulatory shock as it allows correction of preload-dependent low cardiac output states, while preserving patients of the deleterious effects of excessive fluid resuscitation. Patients with severe acute respiratory distress syndrome (ARDS) treated with prone positioning (PP) are a specific subset of patients, as 1) they frequently present with shock; 2) excessive fluid administration may lead to respiratory worsening due to increased hydrostatic oedema with potential subsequent worse clinical outcome; and 3) all available dynamic tests evaluating fluid responsiveness can only be performed in patients in the supine condition (which in the case of severe ARDS patients in PP occurs only for 8h over 24h). These elements warrant the development of specific tests allowing the clinician to predict fluid responsiveness with enough exactitude when caring for these patients. We hypothesize that there exists diagnostic heterogeneity in the predictive performance of 4 clinical tests to identify fluid responsiveness in ARDS patients in PP. For the matter of this study, these 4 tests are the Trendelenburg maneuver, the end-expiratory occlusion test, the end-expiratory occlusion test associated with the end-inspiratory occlusion test, and the tidal volume challenge. The diagnostic reference of the study will be the relative change in cardiac index measured by transpulmonary thermodilution before and after a 500 ml fluid bolus, and will allow the adjudication of patients as being fluid responsive or not. The primary objective of the study is to determine the area under the ROC curve of each of the 4 tests, with their respective 95% confidence interval. All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. Patients will only participate once. The expected duration of study participation is 30 minutes maximum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute respiratory distress syndrome, Fluid responsiveness, Fluid resuscitation, Cardiac output, Cardiac preload, Prone position, Continuous cardiac output monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Arm Title
Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver
Arm Type
Experimental
Arm Description
All enrolled patients will perform the 4 tests following a cross-over design and in a randomized sequence, separated by 1-min wash-out periods with return to hemodynamic baseline values, and concluded with the 500-ml fluid bolus. There are 24 different possibilities of sequence
Intervention Type
Diagnostic Test
Intervention Name(s)
Trendelenburg maneuver
Intervention Description
Bed tilting from the +13° position to the -13° position for 60 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the highest value observed during the maneuver
Intervention Type
Diagnostic Test
Intervention Name(s)
End-expiratory occlusion test (EE OCC)
Intervention Description
End-expiratory pause performed on the ventilator, and maintained for 15 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the value observed in the last 5 seconds of the respiratory pause
Intervention Type
Diagnostic Test
Intervention Name(s)
End-expiratory and end-inspiratory occlusion test (EI OCC)
Intervention Description
End-inspiratory pause performed on the ventilator, and maintained for 15 seconds. Evaluator: relative change in continuous cardiac index between baseline, and the value observed in the last 5 seconds of the respiratory pause. The evaluator is calculated as the sum of the relative change in cardiac index observed during the end-expiratory pause and that of the end-inspiratory pause. Hence, for this test, the evaluator will be coupled with that of intervention 2 (end-expiratory occlusion test).
Intervention Type
Diagnostic Test
Intervention Name(s)
Tidal volume challenge
Intervention Description
Increase in tidal volume set on the ventilator from 6 ml.kg-1 of predicted body weight, to 8 ml.kg-1 for 60 seconds. Evaluator: difference in the pulse pressure variation measured at 6 ml.kg-1 and at 8 ml.kg-1.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fluid bolus (reference diagnostic method)
Intervention Description
After the 4 tests, the patient will receive a 500-ml fluid bolus of crystalloids in less than 15 minutes. Evaluator (reference method): cardiac index measured by transpulmonary thermodilution before and immediately after the fluid bolus. Patients with a relative change in cardiac index > 15% will be identified as being fluid responders, and the others as non-responders.
Primary Outcome Measure Information:
Title
Area under the ROC curve (AUROC) of the evaluated tests.
Description
The AUROC will be determined for each of the 4 clinical tests evaluated in this study. The reference method to define the AUROC to design the curve will be the fluid responsive status (responder vs. non-responder) as determined by the fluid bolus. For each test, the AUROC will be accompanied with its 95% confidence interval.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Comparison of diagnostic performance of the evaluated tests.
Description
For this outcome measure, the AUROCs will be determined as for the primary outcome measure. The AUROCs will be compared using the Delong's method, with adjustments for the repetition of measurements in a single patient.
Time Frame
30 minutes
Title
Diagnostic performance metrics of each test
Description
Sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the evaluated tests, computed for the optimal diagnostic threshold determined using the Youden J index of the ROC curve. The optimal threshold will only be computed for AUROCs significantly different from 0.5.
Time Frame
30 minutes
Title
Weighted diagnostic performance of each test
Description
Sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratios of the evaluated tests, computed for the optimal diagnostic threshold determined using the Youden J index of the ROC curve, and adjusted using weighting based on the clinical tradeoff of the subsequent fluid bolus on hemodynamic benefit vs. the respiratory risk. The optimal threshold will only be computed for AUROCs significantly different from 0.5.
Time Frame
30 minutes
Title
Grey zone area of the optimal diagnostic threshold of each test
Description
Determination of the boundaries of a grey zone around the value of the optimal threshold of each test, in which the diagnostic performance is deemed clinically insufficient (excessive misclassification risk due to lack of discrimination). The grey zone around the optimal threshold will only be computed for AUROCs significantly different from 0.5.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patient (including patient under protective measures/wardship) with ARDS as defined by the Berlin criteria in the prone position as per international guidelines with a calibrated continuous cardiac output monitoring device with a clinical indication for a fluid bolus as prescribed by the clinician in charge, and fulfilling at least 2 clinical criteria: mottles, tachycardia, hypotension, drop in cardiac output, oliguria, high arterial lactate concentration, or any other detailed criterion with no respiratory efforts Exclusion Criteria: acute cor pulmonale patient treated with veno-venous extra-corporeal membrane oxygenation hemorrhagic shock Child-Pugh C cirrhosis death expected to occur in less than 24h decision to withhold or suspend active treatments intracranial hypertension lower limb amputation obstruction of the inferior vena cava acute abdominal syndrome absence of consent to participate pregnancy patient previously enrolled in the same study lack of affiliation to a social security regimen, as per French legislation patient deprived of its liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BITKER, Dr
Phone
4 26 10 94 93
Ext
+33
Email
laurent.bitker@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Jozwiak, Dr
Phone
4 92 03 55 10
Ext
+33
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hodane YONIS, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Dupuis, Dr
Phone
4 73 75 49 82
Ext
+33
Email
cdupuis1@chu-clermontferrand.fr
Facility Name
Hôpital de la Croix Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BITKER, Dr
Phone
4 26 10 94 93
Ext
+33
Email
laurent.bitker@chu-lyon.fr
Facility Name
CHU de Nice - l'Archet 1
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Jozwiak, Dr
Phone
4 92 03 55 10
Ext
+33
Email
jozwiak.m@chu-nice.fr

12. IPD Sharing Statement

Learn more about this trial

Fluid Responsiveness Prediction During Prone Position

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