Functional Outcomes in Children Post Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change in functional status
研究概览
简要总结
Improvements in medical care have led to decreasing mortality rates in critically ill children, which have been reported to be as low as 5%. However, surviving critical illness does not necessarily translate to a return to pre-critical illness functional and developmental levels. Adult literature has shown that critical illness increases functional disability for up to five years post intensive care unit stay. We hypothesize that children experience similar functional disabilities as a result of critical illness, which may, as in adults, be primarily due to muscle wasting. The aim of this prospective observational pilot study is establish the relationship between intensive care unit stay and functional outcomes in pediatric survivors of critical illness.
详细描述
Background:
Mortality rates in critically ill children have decreased significantly in recent years, with current rates reported to be as low as 5%. However, increased survival may result in significant morbidity. Herridge et al. demonstrated that adults admitted to the intensive care unit (ICU) for acute respiratory distress syndrome experienced functional disability which persisted up to 5 years after their ICU stay. There now exists a substantial body of literature that adult critical care survivors suffer significant impairment in their quality of life, which is a growing public health issue.
In critically ill children, Namachivayam et al. showed that among children with pediatric intensive care unit (PICU) stay > 28days, 34% of survivors had an unfavourable functional outcome (defined as moderate or severe disability with dependence on others for care as measured by the Glasgow Outcome Scale). Health related quality of life was also affected, with 68% of survivors having poorer quality of life scores as measured by the Health State Utilities Index. Thus, clinicians have argued that mortality may not be the most meaningful outcome measure for PICU patients. Alternative outcome measures such as functional status and quality of life of children post critical illness may give a better overall assessment of how well children cope with surviving critical illness, and how their normal development is affected.
In adults there is a growing understanding of the burden of critical care survivors on families and caregivers. Limited data exists regarding the families and caregivers of survivors of pediatric critical illness, and local data is lacking.
Aim:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anticipated at least 48 hours of PICU stay
- •At least 1 organ dysfunction
- •Expected to survive to PICU discharge
排除标准
- •Amputations
- •Pre-existing progressive neuromuscular disease
- •Oncological disease
- •Premature infants, before corrected gestational age 1 month
- •Healthy controls group
- •Inclusion criteria:
- •No pre-existing medical condition requiring active treatment
结局指标
主要结局
Change in functional status
时间窗: PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge
Change in Functional Status Scale (FSS) scores from baseline
次要结局
- Change in functional status(Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge)
- Caregiver health related quality of life(Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge)
- Rectus femoris cross-sectional area(Baseline, Day 3, 7, 10 of PICU stay, PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge)
- Health related quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0 generic module and Infant scales(PICU discharge (expected average 7 days from admission), hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge)
- Hand grip strength(Hospital discharge (expected average 17 days from PICU admission), 6-12 months post discharge)