An interventional study of pulmonary aeration in supine and ventral decubitus in ARDS, sponsored by Centre Hospitalier de Bastia. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Centre Hospitalier de Bastia · Not applicable, Interventional, and Supportive care
Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to prone positioning (PP) in ARDS patients. The combination of lateralization in prone position has not been studied. The dynamic created by lateralization could allow better overall ventilation during PP, thus making it possible to further improve oxygenation. The main objective of this prospective, bicentric, open, single group study with repeated measures will be to demonstrate that the addition of repeated 30-minute periods of 30° lateralization improves pulmonary aeration in the supine and prone positions in patients with moderate to severe ARDS.
Primary objective: assessment of the distribution of tidal volume after lateralization and according to the position (supine position SP, prone position, PP) by measuring global and regional changes (4 regions of interest from the retrosternal region to the prevertebral region) of pulmonary aeration assessed by electrical impedance tomography (EIT). The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the change in end-expiratory lung impedance (EELI) = [ΔEELI x (VT/ΔZ)] where VT is the tidal volume and ΔZ is the impedance change.
Main secondary objective: assessment of perfusion and gas exchange after each period of lateralization compared to the baseline period in supine position (baseline SP) and in ventral position (baseline PP) (endpoints: PaO2/FiO2 and PaCO2)
Other secondary objectives:
This is the only study on the registry with Centre Hospitalier de Bastia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Non-inclusion criteria:
Patients with at least one of the following criteria will not be eligible:
Exclusion criteria:
Baseline assessment in SP followed by repeated 30-minute lateral decubitus sessions on each side (with a 30° inclination) with a right/left alternation (total duration, 1 hour). During this period, the upper part of the bed will be inclined by 30°. The patients will then be positioned in prone position for a period of 6 hours after which, the same alternating lateral decubitus pattern (repeated 30-minute lateral decubitus sessions on each side with a right/left alternation ) will be applied for 12 hours while the patient is still in prone position. After turning back to the supine position, a 1-hour observation period will be respected before the last measurements are taken. The total duration of the intervention will thus be 20 hours.
Other: pulmonary aeration in supine and ventral decubitus
The addition of repeated periods of 30 minutes of lateralization of 30° amplitude in dorsal decubitus and in ventral decubitus in patients with moderate to severe ARDS. Included patients will benefit from sessions of lateral decubitus for 30 minutes on each side (with an inclination of 30°) with alternation right/left (total one hour). During this period, the upper part of the bed will be inclined by 30°. Patients will then be positioned in strict prone position for a period of 6 hours after which, the same pattern of alternating lateral decubitus will be applied for 12 hours while the patient is still in the prone position. After reversal in supine position, an observation period of 1 hour will be respected before carrying out the last measurements. The total duration of the intervention will be 20 hours.
modification of pulmonary aeration
Evaluation of the distribution of tidal volume after lateralization and according to the position (supine: SP, prone: PP) by measuring global changes and regional (4 regions of interest from the retro-sternal region to the pre-vertebral region) of ventilation lung assessed by electrical impedance tomography (EIT).The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the variation in end-expiration pulmonary impedance (EELI) = \[ΔEELI x (VT/ΔZ)\] where VT is the tidal volume and ΔZ the impedance variation.
Time frame: Up to 25 hours.
Assessment of gas exchange
Assessment of gas exchange (by blood gas analyses) after each each lateralization period compared with the baseline period in dorsal position (SP) and prone position (baseline PP) (endpoints: PaO2/FiO2 and PaCO2)
Time frame: Up to 25 hours
Assessment of lung perfusion
Assessment of lung perfusion by EIT (administration of 10 ml 7.5% hypertonic saline during an expiratory pause)
Time frame: Up to 25 hours
Estimated PaO2/FiO2 ratio > 150
Evaluation of the percentage of patients with a PaO2/FiO2 ratio \> 150 at the end of the supine lateralization period
Time frame: Up to 25 hours
Measurement of lung aeration
Comparisons of : baseline SP with baseline PP, 6-hours PP, PP and lateral positioning (LP) 12h and return to supine for 1h (End), baseline PP with PP 6 hours, PP and lateral positioning (LP) 12h, LP in SP for 6h with LP in PP for 12h and LP comparisons in PP for 12h with return to supine for 1h (End) for pulmonary aeration, (endpoints: PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure).
Time frame: Up to 25 hours
Gas exchange assessment
Comparisons of baseline SP with baseline PP, 6-hours PP, PP and lateral positioning (LP) 12h and return to supine for 1h (End), baseline PP with PP 6 hours, PP and lateral positioning (LP) 12h, LP in SP for 6h with LP in PP for 12h and LP comparisons in PP for 12h with return to supine for 1h (End) for gas exchanges (endpoints: PaO2/FiO2 and PaCO2).
Time frame: Up to 25 hours
Measurement of ventilatory parameters
Comparisons of baseline SP with baseline PP, 6-hours PP, PP and lateral positioning (LP) 12h and return to supine for 1h (End), baseline PP with PP 6 hours, PP and lateral positioning (LP) 12h, LP in SP for 6h with LP in PP for 12h and LP comparisons in PP for 12h with return to supine for 1h (End) for ventilatory parameters (plateau pressure, driving pressure, compliance, elastance).
Time frame: Up to 25 hours
Adverse effects
Evaluate adverse effects associated with the use of lateral positioning.
Time frame: Up to 25 hours
Plan to share: Yes — Only IPD used in the results publication
Supporting information: Study protocol, Icf, Csr
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