Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score
研究概览
简要总结
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). We will assess content validity with an expert panel, feasibility in a pilot run, test-retest reliability, internal consistency, and criterion validity against established clinical scores.
详细描述
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the Turkish version of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) for use in pediatric intensive care settings.
The study will be conducted in the Pediatric Intensive Care Unit (PICU) of Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The translation and cultural adaptation will follow internationally accepted guidelines, including forward and backward translation, expert panel review, and pilot testing.
Following pilot testing, psychometric evaluation will include assessments of internal consistency, test-retest reliability, and criterion validity by comparison with established clinical scores such as the Functional Status Scale (FSS), Glasgow Coma Scale (GCS), and Pediatric Logistic Organ Dysfunction (PELOD) score. Feasibility and safety will be analyzed based on completion rate, administration time, and occurrence of adverse events.
The study population will include children aged 2-18 years who are admitted to the PICU and are clinically stable enough for bedside physical function assessment.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to 18 years
- •Admitted to the pediatric intensive care unit (PICU)
- •Clinically stable for bedside assessment
- •Parental or guardian informed consent obtained (and child assent when appropriate)
- •Able to perform or be observed for at least one item of the cCPAx-TR
排除标准
- •Unstable hemodynamics or severe hypoxemia that prevents safe assessment
- •Deep sedation or neuromuscular blockade that prevents observation at both assessments
- •Severe orthopedic or neurological conditions (for example, unstable fractures or acute paralysis) that prohibit safe mobilization
- •Expected death or withdrawal of care within 24 hours
- •Refusal of consent by parents or guardians
结局指标
主要结局
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score
时间窗: two measurements conducted 48 hours apart
The intraclass correlation coefficient (two-way mixed, absolute agreement) for the cCPAx-TR total score between two assessments administered 48 hours apart in clinically stable participants.
次要结局
未报告次要终点
研究者
Ayse Asik
Pediatric Critical Care Fellow, Department of Pediatrics
Goztepe Prof Dr Suleyman Yalcın City Hospital