Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)
研究概览
详细说明
It is estimated that 40% of the duration of mechanical ventilation is devoted to the weaning process. A length of stay in the ICU of more than 7 days appears to be associated with a 27,9% risk of developing infections. Furthermore, the mortality rate is higher in patients with infections. Additionally, the daily cost of hospitalizing a patient on mechanical ventilation is estimated at €1,590-€1,657, while this varies depending on the interventions required. The burden on the National Health System from the prolonged stay of patients in the ICU, as well as from the complications that will arise, increases exponentially.
It has been found that implementing an IMT program can lead to rapid and successful extubation of the patient, while early mobilization can accelerate timely discharge from the ICU. This optimizes the cost-effectiveness ratio in intensive care units.
The investigators believe that implementing an IMT program will maximize the effectiveness of the early mobilization program for ICU patients. Thus, the investigators believe it will provide valuable insights into the rehabilitation needs of critically ill patients, contributing to earlier weaning from mechanical ventilation and transition to the next level of care. The investigators hypothesize that the implementation of such an intervention program will reduce the length of hospital stay, while also lowering the cost of daily care.
This is a randomized control trial that investigates the effectiveness of an inspiratory muscle training program in successful weaning of mechanically ventilated patients for at least 72 hours. Both experimental groups will receive a protocolised early mobilization program. IMT intervention will be applied till ICU discharge once a day for 5 days/week initiating with a load of 40% of maximal inspiratory pressure (MIP). Primary outcome will be a successful weaning from MV. And secondary includes MV duration, MIP, maximal expiratory pressure (MEP), ICU and hopsital length of stay.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：IRINI PATSAKI, PhD
- 电话号码：+30 6942064363
- 邮箱：ipatsaki@uniwa.gr
学习地点
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Chalcis、希腊
- 招聘中
- General Hospital
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接触：
- Stiliani Andreadou, MSc
- 电话号码：+306942064363
- 邮箱：s.andreadou@gmail.com
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Nikaia、希腊
- 招聘中
- General Hospital "Agios Panteleimon"
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接触：
- Stavroula Fokidi, MSc
- 电话号码：+306942064363
- 邮箱：sfokidi@uniwa.gr
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首席研究员：
- Stavroula Fokidi, MSc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- ≥ 72h invasive mechanical ventilation
- adequate co-operativeness as assessed by 5SQ ≥ 3.
Exclusion Criteria:
- terminal condition or palliative care
- neuromuscular or neurological conditions prior to ICU admission
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：IMT Group
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets. Additional, a protocolized early mobilization program will be perfromed. |
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets
Protocolized early mobilization program
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有源比较器：Control Group
A protocolized early mobilization program
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Protocolized early mobilization program
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weaning sucess
大体时间：immediately after intervention
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Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal
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immediately after intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weaning duration
大体时间：immediately after intervention
|
Duration of weaning procedure
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immediately after intervention
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|
Maximal Inspiratory Pressure
大体时间：1st day (baseline), immediately after intervention
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Maximal inspiratory Pressure
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1st day (baseline), immediately after intervention
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Maximal expirartory pressure
大体时间：1st day (baseline), immediately after intervention
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1st day (baseline), immediately after intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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