Efficacy of the "Start to Move" Protocol on Functionality, Delirium and Acquired Weakness in ICU. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change of Functionality of the Critically Ill Patient (Intra-hospital)
研究概览
简要总结
Background: ICU hospitalization is associated with loss of strength, functionality and delirium. The "Start to Move protocol" demonstrated efficacy in improving and minimizing such effects.
Aim: To evaluate the effectiveness of the "Start to move protocol" compared with conventional treatment in ICU subjects on functionality, weakness acquired in the Intensive Care Unit (ICU-AW), incidence of delirium, days of invasive mechanical ventilation (IMV), ICU stay and 28-day mortality.
Methods: Randomized controlled clinical trial. Including adults ≥15 years with IMV >48 hours, randomized into Start to move and conventional treatment groups.Functionality, ICU-AW incidence, delirium incidence, IMV days, ICU stay and mortality-28 days were analyzed.
详细描述
Introduction:
Individuals hospitalized in Intensive Care Units are subjected to a prolonged state of rest and to various factors that directly or indirectly affect the muscular and organic structure, which can result in ICU-acquired weakness (ICU-AW) and a limitation in functional performance.
These factors can be divided into metabolic, pharmacological and organic, where sustained hyperglycemia, corticosteroid use, sedation-analgesia, neuromuscular blockade and multiorgan failure associated with sepsis or septic shock stand out. This state translates into a direct loss of muscle mass, specifically of type II fibers, physiologically explained by an increase in the myosin protein degradation process, a decrease in protein synthesis and an increase in proinflammatory cells that favor the weakness of the critically ill patient.
Brower et al. studied that the effects of prolonged rest produce a deconditioning and atrophy of the musculature. After 14 days of immobilization, young people and adults are exposed to a 9% loss of quadriceps muscle mass, which translates into a loss of muscle strength of up to 27%.In subjects subjected to invasive mechanical ventilation, it has been shown that the cross-sectional area of the quadriceps muscle can decrease up to 12.5% in the first week of their stay in the ICU, which can increase up to 15.7% if they present multiorgan failure versus a 3% loss in subjects with single organ failure.
ICU-AW and loss of function are also directly related to the prolonged use of sedoanalgesia, neuromuscular blockade and a higher incidence of delirium in the ICU. The presence of delirium is related to low participation in physical therapies, either by decreased cooperation and/or psychomotor agitation, thus directly influencing muscle status and subsequent functional recovery.
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 (Participant, Outcomes Assessor)
盲法说明
The study was conducted in a single 12-bed ICU clinical center, during 2018-2019. Subjects who met the inclusion criteria were asked for informed consent from the responsible guardian and were subsequently randomized (1:1) into Start to move group and conventional treatment group. Sequentially numbered sealed envelopes were used for allocation, which were accessed only by research personnel not participating in the clinical trial.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects admitted to ICU
- •Adults ≥15 years
- •IMV requirement >48 hours
排除标准
- •Neuromuscular disease
- •Psychiatric history (attempted autolysis, schizophrenia, senile dementia or others, who due to their condition are unable to follow simple orders, which could bias the assessment and functional treatment)
- •Limb amputation
- •Pregnancy
- •Cardiorespiratory arrest with severe hypoxic-ischemic brain damage
- •Total dependence prior to hospitalization, according to Barthel index (<20 points);
- •Subject without consenting to participate in the study.
结局指标
主要结局
Change of Functionality of the Critically Ill Patient (Intra-hospital)
时间窗: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Through the FSS-ICU evaluation scale, a score of 0 to 35 points is made to evaluate the motor function of the critical patient, where the higher the score, the greater the subject's functionality.
Change of Functionality of the Critically Ill Patient (pre-hospitalization)
时间窗: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
Evaluation of the Barthel index of a family member, of the baseline state of the patient, before hospitalization. The total score is 100 points, the higher the score, the better the patient's baseline functionality.
Change of ICU-acquired weakness
时间窗: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
ICU-AW was measured through the MRC scale of 60 points, where scores below 48 points indicate ICU-AW and more than 48 points the greater the strength of the subject.
Change of Delirium
时间窗: It is measured in the first 24 hours of the awakening phase of the patient in the 24 hours prior to discharge from the ICU.
It is measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale to determine the presence of delirium. It does not have a score, if it meets criteria the subject will have delirium.
次要结局
- ICU stay (days)(It is measured in the 24 hours prior to discharge from the ICU.)
- Days of invasive mechanical ventilation (IMV)(It is measured in the 24 hours prior to discharge from the ICU.)
- Mortality at 28 days, post ICU discharge(Measured at 28 days post ICU discharge.)
研究者
Sebastian Soto López
Physical Therapist
Hospital Felix Bulnes