Brachial Plexus Injury After Prone Positioning in Intensive Care Unit: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of patients with signs of brachial plexus injury (BPI)
研究概览
简要总结
The goal of this prospective observational study is to estimate the prevalence of brachial plexus injury after prone positioning in patients with ARDS and to evaluate the safety of swimmer position. The main questions it aims to answer are:
- Could arm positioning during pronation play a role in the development of any nerve injury at the brachial plexus level?
- Is swimmer position safe when adopted during prone positioning?
Participants will be studied at selective time points using EMG assessment.
详细描述
Prone positioning will be performed according to the current guidelines. Particularly, face and limbs will be placed according to the "swimmer position", ensuring the face position in the direction of ventilator and limbs (one arm above head and opposite arm at side) positioned as to prevent abnormal extension or flexion against the shoulders and elbows. Patients will lie on low air loss pressure mattresses, thus avoiding the utilization of any thoraco-pelvic supports, which are not recommended. Electromyography (EMG) will be performed to evaluate the occurrence of brachial plexus injury (BPI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥ 18 years old
- •Admission to ICU for severe ARDS
- •Administration of sedation and neuromuscular blocking agents
- •Presence of endotracheal intubation and mechanical ventilation
- •Use of prone positioning to treat hypoxemia
排除标准
- •Extracorporeal membrane oxygenation
- •Prone positioning performed in other centers
- •Prone positioning contraindications
- •Neurodegenerative disorders
- •Previous known brachial plexus injury
结局指标
主要结局
Number of patients with signs of brachial plexus injury (BPI)
时间窗: EMG will be perform at the end of the every cycle of prone positioning (each cycle is 16 hours on average) and within 24 hours before ICU discharge
Signs of BPI are the presence of (almost one of four EMG results): * Somatosensory Evoked Potential N20 latency of radial nerve and ulnar nerve \> 10% compared to baseline * Somatosensory Evoked Potential N20 amplitude of radial nerve and ulnar nerve \< 50% compared to baseline * Sensory Action Potential amplitude of radial nerve, ulnar nerve and median nerve \< 50% compared to baseline * Compound Motor Action Potential amplitude of ulnar and median nerve \< 50% compared to normative data (assessed before ICU discharge)
次要结局
- Safety of swimmer position adopted(The safety of the swimmer position will be evaluated within 24 hours before ICU discharge)
研究者
Filippo Binda
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico