Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)
研究概览
简要总结
This study evaluates the safety and effectiveness of an early rehabilitation program in a pediatric intensive care unit (PICU). Half of the participants will receive intensive and frequent an early mobilization program and others will receive conservative mobilization program.
详细描述
The 14 early rehabilitation sessions(10=physical therapy, 4=occupational therapy) occurred per week over a 2-week period (excluding weekends) in the early rehabilitation group for 15 minutes each. The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children admitted to the PICU due to critical illness
- •Children aged 1-18 years
排除标准
- •Increased intracranial pressure(ICP)
- •History of brain surgery
- •Children with fracture
- •Admitted to the participating PICU ≤ 3 days
- •Children with suspected brain death
研究组 & 干预措施
Early intervention group
The 14 early rehabilitation sessions(10 physical therapy sessions; 15minutes per session, 4 occupational therapy sessions; 20minutes per session) occurred per week until discharge.
干预措施: Early rehabilitation protocol for children hospitalized in the PICU (Other)
Control group
The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.
结局指标
主要结局
Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)
时间窗: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
Functional Status Scale (FSS) domains of functioning included mental status, sensory functioning, communication, motor functioning, feeding, and respiratory status, categorized from normal (score = 1) to very severe dysfunction (score = 5). FSS scores ranged from 6 to 30.
次要结局
- Hospital length of stay (days)(From Baseline to hospital discharge)
- Canadian Occupational Performance Measure (COPM)(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test(PEDI-CAT)(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- The Pediatric Risk of Mortality III (PRISM III)(At PICU admission)
- Muscle strength measures of elbow flexor and knee extensor obtained with a hand-held dynamometer(MicroFET2).(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- Pediatric Sequential Organ Failure Assessment(pSOFA)(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- Duration of mechanical ventilation (days)(Perioid between intubation and extubation of mechanical ventilation)
- PICU length of stay (days)(From PICU admission to discharge)
- Safety index(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- Number of patients discharged from the hospital to a place other than home(At hospital discharge)
- Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months)(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
- Change From baseline The State-Trait Anxiety Inventory (STAI) at follow-up test(2 months)(Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center