NCT06647784

Lateral Positioning and Prone Positioning in ARDS Patients

Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Hospitalier de Bastia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Evaluation of the percentage of patients who, at the end of the period of lateralization in supine position (T2), have a PaO2/FiO2 ratio \> 150 * Comparisons baseline SP with baseline PP, PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure). * Baseline PP comparisons with PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure) * LP comparisons in SP for 6 hours with LP in PP for 12 hours for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure) * LP comparisons in PP for 12 hours with return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure) : PaO2/FiO2 and PaCO2, (EELI) = \[ΔEELI x (VT/ΔZ)\], plateau pressure, driving pressure) * Evaluate the adverse effects related to the use of lateral positioning.

Conditions

• ARDS

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-01-31
• Completion: 2026-10-31
• First posted: 2024-10-18
• Last updated: 2025-05-15

Locations

2 sites across 1 country: France