Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS

• Conditions: Acute Respiratory Distress Syndrome in Adult or Child; Acute Respiratory Distress Syndrome
• Interventions: Other: Prone position in patients with ARDS

• Registration Number: NCT04635267
• Lead Sponsor: Bicetre Hospital

Brief Summary

The study will investigate the influence that extravascular lung water index (EVLWi) could have on the efficacy and persistance of efficacy of prone position in patients with acute respiratory distress syndrome.

Prone position will increase blood oxygenation in 75% of the cases and will be persistant in half of the cases. Unfortunately, no clinical criteria has been found correlated with efficacy. The quantity of lung edema, with increased lung weight, could be a determinant factor of efficacy and the persistance of the efficacy. EVLWi, assessed with the PiCCO2 device, reflects the quantity of fluid accumulated in interstitial and alveolar spaces.

The hypothesis is that patients with higher EVLWi will have less efficacy of prone position in oxygenation and also that the beneficial effects of prone position will last shorter compared to patients with lower EVLWi.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥18 years
• Presence of acute respiratory distress syndrome
• Decision to perform prone position according to the physician in charge of the patient
• Hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Allemagne)

Exclusion Criteria

• Absence of affiliation to the French Sociale security
• Patient under a tutelage measure or placed under judicial protection
• Known pregnancy
• Currently receiving ECMO therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with ARDS	Prone position in patients with ARDS	-

Primary Outcome Measures

Name	Time	Method
Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio during prone position.	up to 24 hours	EVLWi is the amount of water contained in the lungs outside the pulmonary vasculature. It can be measured using the transpulmonary thermodilution technique with the PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Germany)

Secondary Outcome Measures

Name	Time	Method
Correlation between extravascular lung water index (EVLWi) at the end of prone position and the time course of the recruitment/inflation ratio in the next eight hours after prone position.	up to 24 hours	recruitment/inflation ratio is a validated method to characterize the lung recruitability with high positive expiratory pressure, at the bedside of patients with ARDS
Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the recruitment/inflation ratio during prone position.	up to 24 hours	recruitment/inflation ratio is a validated method to characterize the lung recruitability with high positive expiratory pressure, at the bedside of patients with ARDS
Correlation between extravascular lung water index (EVLWi) at the end of prone position and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio in the next eight hours after prone position	up to 24 hours	EVLWi is the amount of water contained in the lungs outside the pulmonary vasculature. It can be measured using the transpulmonary thermodilution technique with the PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Germany)