Lateral Positioning and Prone Positioning in ARDS Patients

Not Applicable

Recruiting

• Conditions: ARDS

• Registration Number: NCT06647784
• Lead Sponsor: Centre Hospitalier de Bastia

Brief 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.

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Study Start: 2024-11-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-01-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
modification of pulmonary aeration	Up to 25 hours.	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of gas exchange	Up to 25 hours	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)
Assessment of lung perfusion	Up to 25 hours	Assessment of lung perfusion by EIT (administration of 10 ml 7.5% hypertonic saline during an expiratory pause)

Trial Locations

Locations (2)

Bastia General Hospital; 🇫🇷 Bastia, France

North Hospital Marseille; 🇫🇷 Marseille, France