Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weaning mechanical ventilation
研究概览
简要总结
The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
详细描述
The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p <0.05).
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
- Double (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
- •invasive mechanical ventilation
- •patients hemodynamically stable
- •without use of vasoactive drugs
排除标准
- •spindle trauma
- •neuromuscular diseases
- •end-stage disease
- •pneumothorax
- •rib fracture
- •diaphragmatic injury
- •postoperative pulmonary surgeries
- •abdominal disease
- •morbidities that have repercussions on diaphragmatic contraction
- •mechanical ventilation with FiO2 > 60% and PEEP > 10 cm H2O
结局指标
主要结局
Weaning mechanical ventilation
时间窗: through study completion, an average of 15 days
time of mechanical ventilation
次要结局
- extubation success(through study completion, an average of 2 days)
- length of stay in the ICU(through study completion, an average of 15 days)
- death(yes or not death, through study completion, an average of 15 days)
研究者
Rodrigo Gustavo da Silva Carvalho
Principal Investigator
Universidade Federal do vale do São Francisco