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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04635267
Enrollment
200
Registered
2020-11-19
Start date
2021-01-01
Completion date
2022-05-01
Last updated
2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome in Adult or Child

Keywords

ARDS, Prone Position, Extravascular lung water, Lung recruitment

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.

Interventions

OTHERProne 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).

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
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 hoursEVLWi 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

MeasureTime frameDescription
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 hoursrecruitment/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 positionup to 24 hoursEVLWi 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)
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 hoursrecruitment/inflation ratio is a validated method to characterize the lung recruitability with high positive expiratory pressure, at the bedside of patients with ARDS

Contacts

Primary ContactXavier Monnet, MD, PhD
xavier.monnet@aphp.fr+33-(0)6660862669
Backup ContactChristopher Lai, MD
christopher.lai@aphp.fr+33-(0)145212671

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026