Study Results
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Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2023-10-06
2026-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver
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
Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Interventions
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Trendelenburg maneuver
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
End-expiratory occlusion test (EE OCC)
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
End-expiratory and end-inspiratory occlusion test (EI OCC)
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).
Tidal volume challenge
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.
Fluid bolus (reference diagnostic method)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Hodane YONIS, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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CHU Gabriel Montpied
Clermont-Ferrand, , France
Hôpital de la Croix Rousse, Hospices Civils de Lyon
Lyon, , France
CHU de Nice - l'Archet 1
Nice, , France
CHU Nice - Pasteur 2
Nice, , France
Countries
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Central Contacts
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Mathieu Jozwiak, Dr
Role: CONTACT
Facility Contacts
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Other Identifiers
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2023-A00920-45
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL23_0315
Identifier Type: -
Identifier Source: org_study_id
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