Lateral Positioning and Prone Positioning in ARDS Patients

NCT06647784 | Recruiting DMC

• 2 other identifiers: LATPRON-24-01ID-RCB 2024-A01321-46
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

ARDS

Keywords

ARDS; Pulmonary aeration; Supine; prone position; lateralization

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 25 hours.

Secondary Outcomes (2)

• Assessment of gas exchange

  Up to 25 hours

• Assessment of lung perfusion

  Up to 25 hours

Other Outcomes (5)

• Estimated PaO2/FiO2 ratio > 150

  Up to 25 hours

• Measurement of lung aeration

  Up to 25 hours

• Gas exchange assessment

  Up to 25 hours

Study Arms (1)

Lateral and alterning positioning

EXPERIMENTAL

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

Interventions

pulmonary aeration in supine and ventral decubitus OTHER

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.

Lateral and alterning positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years
• ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) \< 150 after optimization of PEEP (P/V curve, R/I ratio), curarization and without prior use of the PP since orotracheal intubation.
• Obtained written consent of the patient, one of his relatives or the previously designated trusted person. As soon as possible, the patient will be informed and his written consent will be obtained
• Beneficiary of health insurance coverage
• Possibility of participating in any other studies whose evaluation criteria do not interfere with those of the study
• 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 at home (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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Bastia: lead
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: collaborator

Study Sites (2)

Bastia General Hospital

Bastia, France, 20604, France

RECRUITING

North Hospital Marseille

Marseille, France, 13915, France

RECRUITING

MeSH Terms

Conditions

Deception

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• laurent papazian, MD,PHD

  Bastia General Hospital

  STUDY DIRECTOR

Central Study Contacts

Laurent Papazian, MD,PHD

CONTACT

0495591039; laurent.papazian@ch-bastia.fr

Antoine Faure, PH

CONTACT

0495591111; antoine.faure@ch-bastia.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Lateralization using a commercialy available bed (Multicare X LINET)

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: November 26, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: When the study will be completed
• Access Criteria: To be determined when the study will be completed

Locations

FR (2)