Lateral Positioning and Prone Positioning in ARDS Patients

Last updated: May 12, 2025
Sponsor: Centre Hospitalier de Bastia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

pulmonary aeration in supine and ventral decubitus

Clinical Study ID

NCT06647784
LATPRON-24-01
ID-RCB 2024-A01321-46
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age of at least 18 years

  • ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) < 150 afteroptimization of PEEP (P/V curve, R/I ratio), curarization and without prior use ofthe PP since orotracheal intubation.

  • Obtained written consent of the patient, one of his relatives or the previouslydesignated trusted person. As soon as possible, the patient will be informed and hiswritten consent will be obtained

  • Beneficiary of health insurance coverage

  • Possibility of participating in any other studies whose evaluation criteria do notinterfere with those of the study

Non-inclusion criteria:

Patients with at least one of the following criteria will not be eligible:

  • Refusal to participate

  • Pregnant, parturient or breastfeeding women

  • Intracranial pressure > 30 mm Hg or cerebral perfusion pressure < 60 mmHg

  • Severe chronic respiratory disease with oxygen therapy or mechanical ventilation athome (except CPAP/BIPAP for obstructive sleep apnea)

  • Chronic interstitial lung diseases

  • Patients on ECMO

  • Weight > 100 kg

  • Severe liver disease Child-Pugh score 12-15

  • Pneumothorax

  • SAPS II score > 75 at inclusion

  • Unstable spinal fracture

  • Contraindications to EIT (pacemaker, implantable defibrillator, skin lesions betweenthe 4th and 5th ribs).

  • Withdrawal (except for ECMO) or witholding treatment decision

  • Any other reason which, according to the investigator, could interfere with theevaluation of the study objectives

  • Person under legal protection measure (guardianship, curatorship, etc.)

  • Person deprived of liberty by a judiciary or administrative decision

Exclusion

Exclusion criteria:

  • Patients who will be unable to complete the 25-hour intervention due to worseningrequiring ECMO, death or organizational problems will be excluded from the analysis.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: pulmonary aeration in supine and ventral decubitus
Phase:
Study Start date:
November 26, 2024
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Bastia General Hospital

    Bastia, 20604
    France

    Active - Recruiting

  • North Hospital Marseille

    Marseille, 13915
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.