Acute Respiratory Distress SyndromePROLOADNCT05898269
Fluid Responsiveness Prediction During Prone Position
A study testing Trendelenburg maneuver, End-expiratory occlusion test (EE OCC) and End-expiratory and end-inspiratory occlusion test (EI OCC) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Trendelenburg maneuver, End-expiratory occlusion test (EE OCC) and End-expiratory and end-inspiratory occlusion test (EI OCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Oct 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mathieu Jozwiak, Dr contact
France4 sites, 4 recruiting
- Not yet recruiting
CHU Gabriel Montpied
Clermont-Ferrand, 63000
Claire Dupuis, Dr, 4 73 75 49 82 ext. +33, cdupuis1@chu-clermontferrand.fr
- Recruiting
Hôpital de la Croix Rousse, Hospices Civils de Lyon
Lyon, 69004
Laurent BITKER, Dr, 4 26 10 94 93 ext. +33, laurent.bitker@chu-lyon.fr
- Not yet recruiting
CHU de Nice - l'Archet 1
Nice, 06200
Mathieu Jozwiak, Dr, 4 92 03 55 10 ext. +33, jozwiak.m@chu-nice.fr
- Not yet recruiting
CHU Nice - Pasteur 2
Nice, 06200
Denis DOYEN, Dr, 04 92 03 55 10 ext. +33, doyen.d@chu-nice.fr
About this study
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
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.
Read more
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- 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)
- Keywords
- Acute respiratory distress syndrome, Fluid responsiveness, Fluid resuscitation, Cardiac output, Cardiac preload, Prone position, Continuous cardiac output monitoring
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg maneuverDiagnostic test
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)Diagnostic test
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)Diagnostic test
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 challengeDiagnostic 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.
Fluid bolus (reference diagnostic method)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
| Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver | Experimental | 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 Receives: Diagnostic Test: Trendelenburg maneuver; Diagnostic Test: End-expiratory occlusion test (EE OCC); Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC); Diagnostic Test: Tidal volume challenge; Diagnostic Test: Fluid bolus (reference diagnostic method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (4)
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start6 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hodane YONIS, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898269
- Sponsor's protocol ID
- 69HCL23_0315
- Other IDs
- 2023-A00920-45
- Acronym
- PROLOAD
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05898269
- Acronym / sponsor ID
- PROLOAD / 69HCL23_0315
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, Fluid responsiveness, Fluid resuscitation, Cardiac output, Cardiac preload, Prone position, Continuous cardiac output monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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-EE OCC-Tidal volume challenge-EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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-Tidal volume challenge-EI OCC-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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-Tidal volume challenge-EE OCC-EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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-EI OCC-Tidal volume challenge-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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-EI OCC-EE OCC-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-Tidal volume challenge-EE OCC-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-Tidal volume challenge-Trendelenburg maneuver-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-Trendelenburg maneuver-EE OCC-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-Trendelenburg maneuver-Tidal volume challenge-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-EE OCC-Trendelenburg maneuver-Tidal volume challenge | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
| Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver, Diagnostic Test: End-expiratory occlusion test (EE OCC), Diagnostic Test: End-expiratory and end-inspiratory occlusion test (EI OCC), Diagnostic Test: Tidal volume challenge, Diagnostic Test: Fluid bolus (reference diagnostic method)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg maneuverBed 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 | Diagnostic test | EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver, EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge, EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver, EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC, EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge, EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC, EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver, EI OCC-EE OCC-Trendelenburg maneuver-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, Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver, Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC, Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver, Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC, Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC, Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC, Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge, Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC, Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge, Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC, Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC, Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC |
| 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 | Diagnostic test | EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver, EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge, EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver, EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC, EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge, EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC, EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver, EI OCC-EE OCC-Trendelenburg maneuver-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, Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver, Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC, Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver, Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC, Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC, Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC, Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge, Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC, Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge, Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC, Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC, Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC |
| 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). | Diagnostic test | EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver, EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge, EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver, EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC, EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge, EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC, EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver, EI OCC-EE OCC-Trendelenburg maneuver-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, Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver, Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC, Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver, Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC, Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC, Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC, Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge, Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC, Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge, Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC, Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC, Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC |
| Tidal volume challengeIncrease 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. | Diagnostic test | EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver, EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge, EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver, EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC, EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge, EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC, EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver, EI OCC-EE OCC-Trendelenburg maneuver-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, Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver, Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC, Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver, Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC, Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC, Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC, Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge, Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC, Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge, Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC, Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC, Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC |
| 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. | Diagnostic test | EE OCC-EI OCC-Tidal volume challenge-Trendelenburg maneuver, EE OCC-EI OCC-Trendelenburg maneuver-Tidal volume challenge, EE OCC-Tidal volume challenge-EI OCC-Trendelenburg maneuver, EE OCC-Tidal volume challenge-Trendelenburg maneuver-EI OCC, EE OCC-Trendelenburg maneuver-EI OCC-Tidal volume challenge, EE OCC-Trendelenburg maneuver-Tidal volume challenge-EI OCC, EI OCC-EE OCC-Tidal volume challenge-Trendelenburg maneuver, EI OCC-EE OCC-Trendelenburg maneuver-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, Tidal volume challenge-EE OCC- EI OCC-Trendelenburg maneuver, Tidal volume challenge-EE OCC-Trendelenburg maneuver- EI OCC, Tidal volume challenge-EI OCC-EE OCC-Trendelenburg maneuver, Tidal volume challenge-EI OCC-Trendelenburg maneuver-EE OCC, Tidal volume challenge-Trendelenburg maneuver- EI OCC-EE OCC, Tidal volume challenge-Trendelenburg maneuver-EE OCC- EI OCC, Trendelenburg maneuver-EE OCC-EI OCC-Tidal volume challenge, Trendelenburg maneuver-EE OCC-Tidal volume challenge-EI OCC, Trendelenburg maneuver-EI OCC-EE OCC-Tidal volume challenge, Trendelenburg maneuver-EI OCC-Tidal volume challenge-EE OCC, Trendelenburg maneuver-Tidal volume challenge-EE OCC-EI OCC, Trendelenburg maneuver-Tidal volume challenge-EI OCC-EE OCC |
Primary outcome
Area under the ROC curve (AUROC) of the evaluated tests.
Time frame: 30 minutes
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.
4 secondary outcomes
Comparison of diagnostic performance of the evaluated tests.
Time frame: 30 minutes
Diagnostic performance metrics of each test
Time frame: 30 minutes
Weighted diagnostic performance of each test
Time frame: 30 minutes
Grey zone area of the optimal diagnostic threshold of each test
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu Jozwiak, Dr contact
Hodane YONIS, Dr principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg maneuver, End-expiratory occlusion test (EE OCC) and End-expiratory and end-inspiratory occlusion test (EI OCC) in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent BITKER, Dr (4 26 10 94 93 ext. +33, laurent.bitker@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve (AUROC) of the evaluated tests. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.