Fluid Responsiveness Prediction During Prone Position
PROLOAD
Evaluation of the Diagnostic Performance of 4 Dynamic Tests Evaluating Preload Dependence in Patients With Acute Respiratory Distress Syndrome in the Prone Position
2 other identifiers
interventional
96
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedStudy Start
First participant enrolled
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 18, 2024
January 1, 2024
3 years
June 1, 2023
January 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 minutes
Secondary Outcomes (4)
Comparison of diagnostic performance of the evaluated tests.
30 minutes
Diagnostic performance metrics of each test
30 minutes
Weighted diagnostic performance of each test
30 minutes
Grey zone area of the optimal diagnostic threshold of each test
30 minutes
Study Arms (24)
Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge
EXPERIMENTALAll 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-EE OCC-Tidal volume challenge-EI OCC
EXPERIMENTALAll 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-Tidal volume challenge-EI OCC-EE OCC
EXPERIMENTALAll 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-Tidal volume challenge-EE OCC-EI OCC
EXPERIMENTALAll 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-EI OCC-Tidal volume challenge-EE OCC
EXPERIMENTALAll 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-EI OCC-EE OCC-Tidal volume challenge
EXPERIMENTALAll 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
EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver
EXPERIMENTALAll 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
EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge
EXPERIMENTALAll 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
EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC
EXPERIMENTALAll 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
EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver
EXPERIMENTALAll 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
EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC
EXPERIMENTALAll 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
EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge
EXPERIMENTALAll 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
EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver
EXPERIMENTALAll 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
EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC
EXPERIMENTALAll 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
EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge
EXPERIMENTALAll 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
EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC
EXPERIMENTALAll 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
EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge
EXPERIMENTALAll 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
EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver
EXPERIMENTALAll 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
Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver
EXPERIMENTALAll 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
Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC
EXPERIMENTALAll 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
Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC
EXPERIMENTALAll 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
Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC
EXPERIMENTALAll 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
Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC
EXPERIMENTALAll 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
Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver
EXPERIMENTALAll 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
Interventions
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 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-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).
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Gabriel Montpied
Clermont-Ferrand, 63000, France
HĂ´pital de la Croix Rousse, Hospices Civils de Lyon
Lyon, 69004, France
CHU de Nice - l'Archet 1
Nice, 06200, France
CHU Nice - Pasteur 2
Nice, 06200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hodane YONIS, Dr
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 12, 2023
Study Start
October 6, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 18, 2024
Record last verified: 2024-01