Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Time taken to 1st mobilise
研究概览
简要总结
This study investigates the impact of introducing an early mobilisation device called the Sara Combilizer on time taken to mobilise in critical care. The investigators will collect baseline data on time taken to mobilise for a period of 4 months, then following a training programme and introduction of the device for a further 4 months
详细描述
Early mobility within the ICU is associated with a number of positive outcomes including reductions in ICU and hospital length of stay and better functional recovery. The exact definition of 'early' mobility is still not defined, with the actual ability to mobilize limited by a number of perceived factors.
The Sara Combilizer is a combined tilt table and stretcher chair, which allows passive transfer of patients out of bed. It is theorized the passive and safe nature of transfer may facilitate earlier mobilisation of patients within critical care. This study aimed to assess whether the introduction of the Sara Combilizer reduced time taken to first mobilize for patients mechanically ventilated for at least 5 days and at risk of ICU acquired weakness.
Patients admitted to a large UK critical care unit during the trial period and ventilated for ≥ 5 days were included in the study. Baseline data was collected prospectively for a period of 4 months. The Sara Combilizer was then introduced for a 1 month training and familiarization period, followed by a further 4 months prospective data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •All adult patients (>18 years) admitted to critical care and ventilated for 5 days or more
排除标准
- •Patients with contraindications to mobilise (e.g. pelvic / spinal fractures)
- •Poor prior level of mobility (<10yards)
- •Neuromuscular disease (e.g. Guillain Barre or Motor Neurone Disease)
- •Mechanical ventilation > 48 hours at another facility prior to admission
- •Expected withdrawal of treatment within 24 next hours
- •Patients who have already commenced mobilisation in the 1st 5 days of admission
- •Obese patients who exceed the weight limit of the product (200 kg)
- •Patients over 6ft5 due to restrictions of the product
- •Severe neurological injury
- •Lower limb amputations
结局指标
主要结局
Time taken to 1st mobilise
时间窗: Throughout ICU admission, average of 2 weeks
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
次要结局
- SOFA score(Throughout ICU admission, average of 2 weeks)
研究者
David McWilliams
Clinical Specialist Physiotherapist
University Hospital Birmingham NHS Foundation Trust