Pilot Study: Validation of Operators and Inter-Evaluator Variability in Diagnostic Strategies for ICU-Acquired Weakness (NMusICU-R)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Inter-rater reliability of quadriceps muscle ultrasound measurements
研究概览
简要总结
The goal of this observational study is to evaluate the feasibility and inter-rater reliability of muscle and peripheral nerve ultrasound for the early detection of ICU-acquired weakness (ICU-AW) in critically ill patients.
The main questions it aims to answer are:
Can ICU physical therapists consistently measure muscle and nerve ultrasound variables such as muscle thickness, cross-sectional area, pennation angle, and echogenicity in critically ill patients?
Do clinical scales (MRC-SS and FSS-ICU) show inter-evaluator agreement and correlate with ultrasound findings?
Participants are adult ICU patients at Clínica INDISA who are undergoing routine neuromuscular assessments by trained physical therapists. Each patient will be evaluated by three independent raters using ultrasound and standardized clinical scales. Data will be collected and analyzed to determine inter-rater reliability and correlations between clinical and imaging findings.
详细描述
This observational, cross-sectional pilot study aims to assess the inter-rater reliability of muscle and peripheral nerve ultrasound and functional clinical scales in the diagnosis of ICU-acquired weakness (ICU-AW). The study involves adult patients admitted to the Adult Critical Care Unit at Clínica INDISA (Santiago, Chile). Participants will undergo muscle ultrasound of the quadriceps (measuring anterior compartment thickness, cross-sectional area, and pennation angle) and peripheral nerve ultrasound (assessing cross-sectional area and echogenicity of specific nerves) performed by three trained physical therapists. Clinical assessments using the MRC Sum Score (MRC-SS) and the Functional Status Score for the ICU (FSS-ICU) will also be performed by each rater.
The main aim is to evaluate the agreement between raters using the intraclass correlation coefficient (ICC) for ultrasound variables and Kendall's W for functional scales. The study will also explore correlations between clinical scores and ultrasound findings using Pearson or Spearman correlation coefficients. Echogenicity will be quantified using ImageJ software.
All procedures are performed at bedside using portable ultrasound equipment, and evaluations follow safety guidelines for critically ill patients. The results of this study will contribute to validating physical therapists as reliable operators for early identification of ICU-AW using ultrasound-based tools and standardized clinical assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Adult patients (≥18 years old) admitted to the Adult Intensive Care Unit (ICU) of Clínica INDISA.
- •Conscious and clinically stable at the time of assessment.
- •Able to provide written informed consent.
排除标准
- •Known allergy to ultrasound gel.
- •Body mass index (BMI) ≥ 30 kg/m².
- •Pre-existing neuromuscular disease.
- •Continuous renal replacement therapy or severe hepatic coagulopathy.
- •Platelet count < 20,000/µL.
- •Lower limb amputation or recent fractures.
- •Ongoing chemotherapy or immunosuppressive treatment with corticosteroids.
- •Epileptic status or pregnancy.
结局指标
主要结局
Inter-rater reliability of quadriceps muscle ultrasound measurements
时间窗: Assessed once within 60 days following ICU admission
Intraclass correlation coefficient (ICC) between three evaluators for ultrasound variables including quadriceps muscle thickness, rectus femoris and vastus intermedius cross-sectional area, and pennation angle.
Peripheral Nerve Ultrasound Inter-Rater Reliability
时间窗: Assessed once within 60 days following ICU admission
Intraclass correlation coefficient (ICC) between three evaluators for cross-sectional area and echogenicity of peripheral nerves (median, ulnar, tibial, and fibular) measured by ultrasound.
次要结局
- Inter-rater agreement of Functional Status Score for the ICU (FSS-ICU)(Assessed once within 60 days following ICU admission)
- Inter-Rater Agreement of MRC Sum Score(Assessed once within 60 days following ICU admission)
- Correlation between clinical scales and ultrasound findings(Assessed once within 60 days following ICU admission)
研究者
Oscar Arellano
PhD. Candidate in Biomedical Sciences
University of Chile