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Assessment of Preload Responsiveness in ARDS Patients During Prone Position (PR-ARDS-PP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04457739
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
Rui Shi, Bicetre Hospital

Brief Summary:
Evaluation of preload responsiveness in ARDS patients during prone position is difficult and only one study showed Trendelenburg manoeuvre can be used in this group of patients. This study aims to investigate whether end-expiratory occlusion test, tidal volume challenge (using the changes in PPV) can be used to evaluate preload responsiveness in patients with ARDS ventilated with a low tidal volume and who underwent a PP session.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Septic Shock Hemodynamic Instability Other: Tidal volume challenge Other: End-expiratory occlusion test Other: Trendelenburg maneuver

Detailed Description:
Acute respiratory distress syndrome (ARDS) which is a major cause of morbidity and mortality in the intensive care unit, is characterized by decreased lung volume, decreased lung compliance, increased pulmonary vascular resistance and pulmonary hypertension, which ultimately lead to right ventricular dysfunction. Moreover, through biventricular interdependence and inter-ventricular septum shift, the left ventricular filling is limited, which eventually results in a decrease in stroke volume. Due to the high risk of ventilation-induced lung injury, protective lung ventilation is recommended, mainly through a reduction in tidal volume. However, due to the profound hypoxemia inherent to this mode of ventilation, lung recruitment strategies are recommended. When the application of a recruitive positive end-expiratory pressure fails to correct hypoxemia, prone positioning (PP) is recommended. A randomized controlled trial (PROSEVA) reported that early application of prolonged PP sessions in patients with severe ARDS significantly decreased 28- and 90-day mortality. In addition to its respiratory effects (improvement in arterial oxygenation and lung recruitment), PP exerts different cardiovascular effects. By increasing oxygenation and recruiting lung regions, PP can reduce the right ventricular afterload. By increasing the intraabdominal pressure (IAP), PP can increase the venous return and the cardiac preload. This effect might depend on the level of IAP, because a high IAP might collapse the inferior vena cava, especially in the case of hypovolemia. If cardiac preload increases, the resultant effect on cardiac output might depend on the degree of preload responsiveness. Finally, by increasing the IAP, PP can increase the left ventricular afterload. In a recent clinical study, our group showed that PP increases right and left ventricular preload and decreased right ventricular afterload. However, PP increased cardiac output only in patients with preload responsiveness. In this study preload responsiveness was detected by an increase in cardiac output > 10% during a passive leg raising (PLR) test. Since PP sessions are recommended to last between 16 to 18 hours per day and since patients with ARDS often have an associated sepsis, hemodynamically instability may occur during PP sessions. The therapeutic decision is very tricky since the administration of fluid (the main therapeutic option in case of hemodynamic instability) is risky due to alteration of lung capillary membrane permeability. Thus, it is important to predict the benefits of fluid administration by using indices of preload responsiveness. The recommended indices of preload responsiveness are pulse pressure variation (PPV), stroke volume variation (SVV) and PLR. However, PPV and SVV cannot be used reliably during low tidal volume ventilation. Moreover, conventional PLR cannot be performed during PP. It is thus important to develop other preload responsiveness tests doable during PP. Our group proposed to perform an end-expiratory occlusion (EEO) test to predict fluid responsiveness in the supine position and more recently to perform a tidal volume challenge (TVC) by transiently increasing tidal volume from 6 to 8 mL/kg and observing the changes in PPV.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Tidal Volume Challenge to Detect Preload-responsiveness in Patients With Acute Respiratory Distress Syndrome (ARDS) During Prone Position
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Intervention Details:
  • Other: Tidal volume challenge
    Increasing tidal volume from 6 to 8 mL/kg during 1 min
  • Other: End-expiratory occlusion test
    Interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output
  • Other: Trendelenburg maneuver
    Patients remained in prone position with a 13° upward bed angulation throughout the study and then be positioned in a declining position at -12 ° for 1 minute

Primary Outcome Measures :
  1. Area under ROC curve of the change in pulse pressure variation during tidal volume challenge to detect preload responsiveness [ Time Frame: 1 minute after increasing tidal volume from 6 to 8mL/kg ]

Secondary Outcome Measures :
  1. Area under ROC curve of the pulse pressure variation in tidal volume of 8ml/kg in continuous cardiac output during end-expiratory occlusion to detect preload dependence [ Time Frame: 1 minute after tidal volume increase to 8 ml/kg ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe ARDS (according to the Berlin definition) undergoing a prone position session, already monitored with a transpulmonary thermodilution device and for whom the evaluation of preload responsiveness is needed owing to the occurrence of hemodynamic instability.

Inclusion Criteria:

  • ARDS patient
  • Prone position
  • Monitored by transpulmonary thermodilution and pulse contour analysis

Exclusion Criteria:

  • Age below 18
  • No social security
  • Refuse to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04457739

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Contact: RUI SHI, MD 0642170297
Contact: JEAN-LOUIS TEBOUL, MD.PhD. 0145213543

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Bicetre Hospital Recruiting
Paris, Val-de-Marne, France, 94270
Contact: JEAN-LOUIS TEBOUL, MD. PhD    0145213543   
Sponsors and Collaborators
Bicetre Hospital
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Responsible Party: Rui Shi, Principal Investigator, Bicetre Hospital Identifier: NCT04457739    
Other Study ID Numbers: 2019-A00064-53
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rui Shi, Bicetre Hospital:
Hemodynamic monitoring
preload responsiveness
Fluid therapy
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury