Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- modification of pulmonary aeration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
modification of pulmonary aeration
时间窗: 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.
次要结局
- Assessment of gas exchange(Up to 25 hours)
- Assessment of lung perfusion(Up to 25 hours)