Clinical trial NCT06647784: Lateral Positioning and Prone Positioning in ARDS Patients
Official title: Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS
Keywords: ARDS
Pulmonary aeration
Supine
prone position
lateralization
Lead sponsor: Centre Hospitalier de Bastia
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
First posted: 2024-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lateralization using a commercialy available bed (Multicare X LINET)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria:

* 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

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 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
* SAPS II score \> 75 at inclusion
* Unstable spinal fracture
* Contraindications to EIT (pacemaker, implantable defibrillator, skin lesions between the 4th and 5th ribs).
* Withdrawal (except for ECMO) or witholding treatment decision
* Any other reason which, according to the investigator, could interfere with the evaluation of the study objectives
* Person under legal protection measure (guardianship, curatorship, etc.)
* Person deprived of liberty by a judiciary or administrative decision

Exclusion criteria:

- 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.

Primary outcomes:
measure: modification of pulmonary aeration
timeFrame: Up to 25 hours.
Secondary outcomes:
measure: Assessment of gas exchange
timeFrame: Up to 25 hours
measure: Assessment of lung perfusion
timeFrame: Up to 25 hours
Other outcomes:
measure: Estimated PaO2/FiO2 ratio > 150
timeFrame: Up to 25 hours
measure: Measurement of lung aeration
timeFrame: Up to 25 hours
measure: Gas exchange assessment
timeFrame: Up to 25 hours
measure: Measurement of ventilatory parameters
timeFrame: Up to 25 hours
measure: Adverse effects
timeFrame: Up to 25 hours
Locations:
city: Bastia
country: France
facility: Bastia General Hospital
city: Marseille
country: France
facility: North Hospital Marseille
Study officials:
affiliation: Bastia General Hospital
name: laurent papazian, MD,PHD
role: STUDY_DIRECTOR
References: