NCT01108575已完成1 期
Inspiratory Muscle Strength Training in Ventilator Dependent Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation support
研究概览
简要总结
A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.
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
- Triple (Participant, Investigator, 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
- •Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.
排除标准
- •inability to follow simple, one step commands such as "inspire forcefully",
- •patients with prior arrangements to be transferred to other facilities when stabilized,
- •any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
- •unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
- •use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
- •severe dysrhythmias,
- •acute coronary syndrome
- •pulmonary contraindications (pneumon/hemothorax, flail chest),
- •acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation.
- •active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
- •spinal cord injuries.
研究组 & 干预措施
Inspiratory muscle strength training
Experimental
干预措施: IMST (Other)
Sham Inspiratory muscle strength training
Sham Comparator
干预措施: Sham IMST (Other)
结局指标
主要结局
Duration of mechanical ventilation support
时间窗: Patients will be observed for up to 28 days following admission to the ICU
次要结局
- Maximal inspiratory pressure(Patients will be observed for up to 28 days following admission to the ICU)
研究者
研究点 (1)
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