Clinical trial NCT04457739: Assessment of Preload Responsiveness in ARDS Patients During Prone Position
Official title: Evaluation of Tidal Volume Challenge to Detect Preload-responsiveness in Patients With Acute Respiratory Distress Syndrome (ARDS) During Prone Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Septic Shock
Hemodynamic Instability
Keywords: Hemodynamic monitoring
preload responsiveness
ARDS
Fluid therapy
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under ROC curve of the change in pulse pressure variation during tidal volume challenge to detect preload responsiveness
timeFrame: 1 minute after increasing tidal volume from 6 to 8mL/kg
Secondary outcomes:
measure: 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
timeFrame: 1 minute after tidal volume increase to 8 ml/kg
Other outcomes:
Locations:
city: Paris
country: France
facility: Bicetre Hospital
state: Val-de-Marne
Study officials:
References:
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