Investigating Modes of Progressive Mobility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.
研究概览
简要总结
The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.
详细描述
The specific aims of this study are to:
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Compare patient responses to selected modes of therapy (activity) without and with an ETM protocol
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Molecular responses: markers of inflammation interleukin (IL)-6 and IL-10
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Physiological responses: peripheral oxygen saturation, heart rate, blood pressure, new dysrhythmias
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Safety/Unsafe events including pain, fatigue, line or tube dislodgement, fall or near fall
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Determine the associations between duration and level of activity/ETM achieved and outcomes:
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occurrence of delirium
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occurrence of ventilator associated pneumonia
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occurrence of deep vein thrombosis or pulmonary emboli
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occurrence of acquired pressure ulcer
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muscle strength
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number of days mechanically ventilated
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discharge location (after ICU)
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Describe strategies used in the ICU to initiate and implement activity with and without an ETM protocol
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use of personnel such as registered nurses, physical therapists, respiratory therapist and nursing assistants
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use of equipment such as a walker, lift device, belt or bed
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perception of sufficient time and abilities
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Describe patient factors that are associated with implementation of ETM
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •P:F ratio > 100
- •FiO2 < 60% and PEEP less than 10 cmH20
- •hemodynamic stability ten minutes after turning (i.e., heart rate (HR) and/or systolic blood pressure (BP) changes less than 20% of baseline)
- •baseline (rest) vitals signs of HR 50-110
- •mean arterial pressure (MAP) 60-100 mmHg
- •peripheral oxygenation saturation (SpO2) greater than 88%
- •Sufficient cognition for progression to levels 2-4 of ETM to assist with out of bed positioning or movement
- •a high degree of dependency on others for positioning is acceptable
- •there are no exclusions based on gender or minority status.
排除标准
- •End-stage muscular dystrophy
- •myasthenia gravis
- •new quadriplegia
- •increased intracranial pressure
- •unrepaired hip fracture and multiple lower extremity fractures
- •Patients experiencing active titration of intravenous vasoactive medications (e.g. dopamine, epinephrine, or norepinepherine) will be excluded
- •concurrent use of a continuous lateral rotation bed
- •patients for high risk of death will also be excluded
- •MICU admission following a hospital stay of >9 days in the past months
- •age >80 in the presence of 2 or more life-threatening illnesses
- •diagnosis of an active stage IV malignancy
- •status post cardiac arrest
- •diagnosis of intracerebral hemorrhage requiring mechanical ventilation
- •subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.
结局指标
主要结局
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.
时间窗: 1, 2, 3, 7, days then weekly
次要结局
- A secondary aim is to identify strategies and conditions that promote or prevent ETM.(1, 3, 5, 7, days then weekly)