ArtificiaL Increase in chesT Wall Elastance as an alteRnative to PRONE Positioning in Moderate-to-severe ARDS: a Physiological Study The ALTERPRONE Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- oxygenation
研究概览
简要总结
During moderate to severe ARDS, sessions of prone positioning lead to lung and chest wall mechanics changes that modify regional ventilation, with a final redistribution of tidal volume and PEEP towards dependent lung regions: this limits ventilator-induced lung injury, increases oxygenation and convincingly improves clinical outcome.
Physiological data indicate that the increase in chest wall elastance is crucial in determining the benefit by prone positioning on oxygenation. In some patients, however, prone positioning may not be feasible or safe due to particular comorbidities and/or technical issues.
In the present pilot-feasibility study enrolling 15 subjects with moderate to severe ARDS in whom prone positioning is contraindicated or unfeasible, we aim at assessing whether and to what extent an artificial increase in chest wall elastance while the patient is in the supine position may yield a significant benefit to oxygenation. The increase in chest wall elastance will be achieved placing 100g/kg weight on the anterior chest wall of the patient while he/she is in the supine position: this approach previoulsy appeared safe and effective in case reports and small case series. Patient's position will be standardized (30 degrees head-up, semi seated position).
This one-arm sequential study will evaluate the effects of the procedure on gas exchange, haemodynamics, lung and chest wall mechanics, alveolar recruitment (measured with the nitrogen washout-technique and multiple PV curves) and tidal volume and PEEP distribution (assessed with electrical impedance tomography).
详细描述
Design: Prospective, pilot, physiological study Setting: 20-bed general ICU, 13 bed surgical ICU, 10 bed neurosurgical ICU, "A. Gemelli" University hospital, Rome, Italy.
Protocol
Screening visit and oxygenation criterion validation Each patient meeting inclusion criteria will be evaluated for the presence of the oxygenation criterion. After endotracheal suctioning, eligible patients will be ventilated for 30 minutes with PEEP=5 cmH2O in the semi recumbent position and an ABG will be performed to compute PaO2/FiO2 ratio.
Patients showing PaO2/FiO2≤150 mmHg will be enrolled. Patients showing PaO2/FiO2<200 and >150 mmHg will be treated according to the standard clinical practice and reassessed for the presence of oxygenation criterion within 48 hours from the diagnosing of ARDS.
To limit the exposure to low PEEP of possibly derecruiting patient with severe oxygenation impairment, the ABG certifying the oxygenation criterion will be permitted at any time during the 30-minute monitoring period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Patients with ARDS and moderate to severe oxygenation impairment (PaO2/FiO2≤150 mmHg while receiving controlled mechanical ventilation with PEEP=5 cmH2O) will be the studied population.
- •Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
- •Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
- •Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
- •PaO2/FiO2 ratio<150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O(14).
- •Written informed consent.
- •Prone positioning deemed non-feasible by the attending clinician, or presence of at least one of the following absolute contraindications for prone positioning(5)
- •Serious facial trauma or facial surgery during the previous 15 days
- •Deep venous thrombosis treated for less than 2 days
- •Unstable spine, femur, or pelvic fractures
- •Pregnant women
- •Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mm
排除标准
- •Chest trauma
- •Cardiothoracic surgery in the last 4/6 weeks
- •Cardiac PM inserted the last 2 days
- •Haemodynamic instability (MAP < 65 mmHg despite vasoactive/inotrope support)
- •Chest tube with air leaks
- •Presence of intrinsic PEEP > 1 cmH2O
- •BMI < 18
- •Height < 150 cm
- •More than 48 hours from endotracheal intubation to the time of randomization
结局指标
主要结局
oxygenation
时间窗: 120 minutes after the intervention
PaO2/FiO2 ratio
次要结局
- Driving pressure(1 and 2 hours after the intervention)
- Chest wall elastance(1 and 2 hours after the intervention)
- Lung stress(1 and 2 hours after the intervention)
- tidal volume dsitribution(1 and 2 hours after the intervention)
- Transpulmonary Driving pressure(1 and 2 hours after the intervention)
- Alveolar recruitment(1 and 2 hours after the intervention)
- Dynamic strain(1 and 2 hours after the intervention)
研究者
Massimo Antonelli
Head of the department of Anesthesia and Intensive care medicine
Catholic University of the Sacred Heart