Protocol for a prospective cohort study on the feasibility of application of nutritional ultrasound in the diagnosis and follow-up of patients with nutritional risk at hospital discharge: Study on body composition and function (DRECO)

Abstract

SUMMARY Background The application of nutritional ultrasound for the morphological and structural study of muscle mass is an emerging technique in clinical nutrition. Currently, all definitions of malnutrition include the measurement of muscle mass involvement, however, there is no single way to assess it. It is necessary to develop new techniques to identify muscle involvement in malnutrition that are valid, standardized, reliable, accurate and profitable. Objectives The objective of this study is to value the new muscle ultrasound techniques aimed to measure muscle and functional status, to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in patients at nutritional risk. Primary outcome: to assess the feasibility of ultrasound or muscle ultrasound techniques in both nutritional diagnosis and follow-up, over 3 to 6 months, in a nutritional intervention program. Methods DRECO (Disease-Related caloric-protein malnutrition EChOgraphy) is a prospective, multicenter, uncontrolled clinical study in standard clinical practice to value the usefulness of nutritional ultrasound (muscle ultrasound) in the nutritional diagnosis and follow-up of patients over a period of 3 to 6 consecutive months, after standard nutritional clinical practice intervention, and physical activity to control their disease-related malnutrition. Discussion This study will standardize nutritional ultrasound measures. It will validate and define specific cut-off values for nutritional ultrasound and get its correlation with already well-known nutritional tools such as SGA (Subjective Global Assessment) or GLIM (Global Leadership Initiative on Malnutrition) criteria. Thus, muscle ultrasound will become not only a tool to assess the diagnosis of malnutrition, but it will be integrated in the routine clinical practices to evaluate nutritional interventions. Registration This study is registered at clinicaltrials.gov (NCT05433831), registered on June 27th, 2022. https://clinicaltrials.gov/ct2/show/NCT05433831.