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

Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With Acute Respiratory Distress Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Distress Syndrome in Adult or Child
• Intervention / Treatment: Other: Prone position in patients with ARDS

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate-to-severe ARDS in whom prone positioning is deemed necessary

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with ARDS	Other: Prone position in patients with ARDS; Transpulmonary thermodilution, arterial blood gas and recruitment/inflation calculation will be made every 8 hours: at baseline (just before prone position), after eight hours of prone position, after 16 hours of prone position (end of prone position), after 24 hours ( 8 hours after the end of prone position).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the recruitment/inflation ratio during prone position.	recruitment/inflation ratio is a validated method to characterize the lung recruitability with high positive expiratory pressure, at the bedside of patients with ARDS	up to 24 hours
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	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)	up to 24 hours
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.	recruitment/inflation ratio is a validated method to characterize the lung recruitability with high positive expiratory pressure, at the bedside of patients with ARDS	up to 24 hours

Collaborators and Investigators

• Sponsor: Bicetre Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: ARDS; Prone Position; Lung recruitment; Extravascular lung water
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2020-A03094-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No