Clinical trial NCT04635267: Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS
Official title: Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome in Adult or Child
Keywords: ARDS
Prone Position
Extravascular lung water
Lung recruitment
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate-to-severe ARDS in whom prone positioning is deemed necessary

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 24 hours
Secondary outcomes:
measure: Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the recruitment/inflation ratio during prone position.
timeFrame: up to 24 hours
measure: 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
timeFrame: up to 24 hours
measure: 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.
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References: