Evaluation of the Validity and Reliability of Muscle Ultrasound in the Detection of Undernutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Reduction in muscle mass measured by ultrasound thickness of the rectus femoris.
研究概览
简要总结
In France, the prevalence of undernutrition in hospitalized patients varies from 30 to 50%. Undernutrition is strongly associated with a decrease in the patient's functional abilities and an increase in morbidity and mortality and healthcare expenses. In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on diagnostic criteria for undernutrition. The diagnostic criteria are numerous, and include etiological criteria such as reduced food intake; an inflammatory setting; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention, and muscle function.
Muscle mass is described as a major diagnostic criterion, since it is on the one hand a direct indicator of protein catabolism related to undernutrition, but also a reflection of functional impairment in the patient, as it is directly associated with functional capacities, autonomy and prognosis. Ultrasound is a reproducible method of muscle assessment. It allows the evaluation of muscle thickness or cross-sectional area of a muscle, the reduction of which, a marker of atrophy, is strongly correlated to its loss of strength and to reference measurements. In addition, ultrasound can be used to assess muscle quality, particularly by evaluating the echogenicity of the muscle. The echogenicity increases when the muscle is altered, linked to the presence of fatty infiltrate and fibrous tissue. The use of ultrasound in the evaluation of the patient's nutritional status, as a tool for assessing muscle function, is developing in the ICU and is associated with an increase in the patient's comorbidities. Studies remain limited to a few patient populations, do not report clear cut-off values to define muscle pathological status, and require more precise definition of ultrasound measurement protocols.
The investigators hypothesize that muscle ultrasound is reliable and valid in the evaluation of muscle function during the screening of undernutrition in a population of patients hospitalized in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years old.
详细描述
- Rationale 1.1 Epidemiology and morbidity of undernutrition Undernutrition, whether related to disease, poverty, hunger, war or natural disasters, affects more than one billion people worldwide. In France, an empirical estimate suggests a prevalence of undernutrition among hospitalized patients of about 2 million or 30 to 50%. It should be noted that undernutrition is very common in and out of hospital. It is widely accepted that undernutrition can be caused by a deficit in nutrient intake or malabsorption. However, it is now known that the inflammatory state present during illness is associated with undernutrition.
1.2 International consensus on the definition of undernutrition
In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on diagnostic criteria for undernutrition. The diagnostic criteria are numerous, and include etiological criteria such as reduced food intake; an inflammatory context; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention, and muscle function. GLIM has chosen to select the most relevant criteria among the etiological and phenotypic criteria:
- Etiological criteria: reduced food intake and inflammatory state of the patient;
- Phenotypic criteria: weight loss, BMI, and reduced muscle mass. The presence of at least one etiological criterion and one phenotypic criterion is mandatory to make the diagnosis of undernutrition.
Muscle mass is described as a major diagnostic criterion, since it is on the one hand a direct indicator of protein catabolism related to undernutrition, but also a reflection of functional impairment in the patient, as it is directly associated with functional capacities, autonomy and prognosis. Different measurement tools are suggested, such as bioelectrical impedancemetry, ultrasound or magnetic resonance imaging, leaving the choice of tool to the clinicians, depending on experience and local resources. Handgrip measurement is considered a complementary measure.
GLIM recommends an assessment of the risk of undernutrition, using validated questionnaires such as the NRS (Nutritional Risk Screening) or the MNA-SF (Mini Nutritional Assessment- Short Form). The degree of severity of undernutrition is only assessed on the basis of phenotypic criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted in short stay and follow-up care and rehabilitation of diabetology-obesity, pneumology, oncology and gastro-nutrition;
- •Age between 18 and 70 years at inclusion;
- •Affiliation with a social security system or beneficiary of such a system ;
- •Oral, free, informed and express consent of the patient or his/her family member.
排除标准
- •Impossible to perform the ultrasound;
- •Impossibility of performing bioelectrical impedancemetry ;
- •Incapacity to consent;
- •Patient refusal to participate in the study;
- •Pregnancy (a pregnancy test should be performed if in doubt);
- •Breastfeeding woman;
- •Person subject to a safeguard of justice measure ;
- •Patient under guardianship or curatorship;
- •Patient in care limitation;
- •Sampling in the ineligible study group.
结局指标
主要结局
Reduction in muscle mass measured by ultrasound thickness of the rectus femoris.
时间窗: Through study completion, an average of 2 years
The primary endpoint is the reduction in muscle mass measured by ultrasound thickness of the rectus femoris. The reduction in muscle mass measured by ultrasound will be used to estimate the diagnostic accuracy of muscle ultrasound using bioelectrical impedancemetry as the reference examination.
次要结局
- Correlation measurements of muscle ultrasound with:(Through study completion, an average of 2 years)
- Comparison of the diagnostic accuracy in undernutrition of muscle ultrasound with those of :(Through study completion, an average of 2 years)
- Measure of association of muscle ultrasound measurements with patient morbi- mortality:(Through study completion, an average of 2 years)