Impact of the Erigo Machine on Functional Recovery in ICU
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Orthostatic Tolerance During Verticalization
研究概览
简要总结
This study will assess the effects of the Erigo applied as part of the early mobilization program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the Erigo, critically ill patients will tolerate verticalization and mobilization earlier and safely resulting in improved outcomes measured by increased mobility and strength on ICU discharge, decreased requirements for mechanical ventilation, reduced complication rates and decreased ICU and hospital LOS.
详细描述
The "Erigo" by Hocoma is a combination of tilt table with a robotic stepper device allowing for cyclic leg loading. Erigo now also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It allows for protected gradual verticalization and mobilization based on patient tolerance and progress. It has been shown to improve orthostatic tolerance, cerebral blood flow and muscle strength.
Prospective Randomized Controlled Trial will compare two groups. The patients that meet inclusion criteria will be randomized into either the treatment group or a control group. General ICU mobility guidelines consist of scaled activity related to the patients' stability. The control group will get the general ICU mobility treatments and the treatment group will have one mobility treatment replaced with the Erigo treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Admission to Trauma ICU
- •Trauma Patients requiring physical therapy (including severe traumatic brain injury or polytrauma without extremity fractures or unstable thoracic or lumbar spine fracture
- •Burn patients requiring physical therapy
- •GI surgery patients requiring physical therapy
- •Necrotizing fasciitis patient requiring physical therapy
排除标准
- •Patients with the following conditions:
- •Non-weight bearing on lower extremities
- •Untreated DVT
- •Active hemorrhage
- •Leg length >102cm or <72cm
- •Weight >135kg
- •Systolic BP > 20mmHg sustained for 10min
- •Heart rate >20bpm outside goal for more than 20min
- •Intracranial pressure (ICP) >20mmHg sustained for 10min if applicable,
- •Temperature >38.2C
研究组 & 干预措施
Erigo Pro plus standard Physical Therapy
The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.
干预措施: Erigo Pro (Device)
Standard Physical Therapy
Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.
干预措施: Standard Physical Therapy (Other)
结局指标
主要结局
Orthostatic Tolerance During Verticalization
时间窗: Up to one year
Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing.
Orthostatic Tolerance During Ambulation
时间窗: Up to one year
Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation.
次要结局
- ICU Length of Stay(Up to three months)
- Hospital Length of Stay(Up to one year)
- Incidence of Pneumonia While Hospitalized(Up to one year)
- Incidence of Pressure Ulcers(Up to one year)
- Incidence of Physical Instability(Up to one year)
- Incidence of Catheter Disruption(Up to one year)
- Measure of Physical Capacity(At discharge (up to 1 year))
- Incidence of Deep Vein Thrombosis (DVT)(Up to one year)
- Incidence of Urinary Tract Infections While Hospitalized(Up to one year)
- Measure of Muscle Power(Up to one year)
- Fall Risk(Up to one year)
- Assessment of Participant Mobility(Up to one year)
- Independent Ambulation(Up to one year)
- Mid-leg Muscle Circumference(Up to one year)
- Number of Patients Discharged From Hospital to Home(Up to one year)
- Number of Patients Discharged From Hospital to Skilled Nursing Facility(Up to one year)
- Number of Patients Discharged From Hospital to a Long Term Care Facility(Up to one year)
- Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility(Up to one year)
研究者
Lisa J. Fryman
Nursing Director Trauma/Surgical Services
University of Kentucky