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

Introduction: Nutritional ultrasound (US) is an emerging technique in clinical nutrition for the morphological and structural study of muscle mass. Currently, all definitions of malnutrition include the measurement of muscle mass; 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, standardised, reliable, accurate and profitable.

Objective: To value the new muscle US 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 US or muscle US techniques in both nutritional diagnosis and follow-up in a nutritional intervention programme.

Methods and analysis: Disease-Related caloric-protein malnutrition EChOgraphy (DRECO) is a prospective, multicentre (25 Spanish hospitals), uncontrolled clinical study in standard clinical practice to value the usefulness of nutritional US (muscle US) in the nutritional diagnosis and follow-up, over 3-6 months, after standard nutritional clinical practice intervention and physical activity, to control their disease-related malnutrition. 1000 patients are expected to be included in.

Discussion: This study will standardise nutritional US measures. It will validate and define specific cut-off values for nutritional US and correlate it with already well-known nutritional tools such as Subjective Global Assessment or Global Leadership Initiative on Malnutrition criteria. Thus, muscle US will become not only a tool to diagnose malnutrition, but it will also be integrated in the daily practice to evaluate nutritional interventions.

Ethics and dissemination: All DRECO study materials have been approved by each of the IRB/IEC of all the sites enrolled (either approval of the own IRB/IEC or validating the approval of the IRB/IEC of another hospital). The study has been registered with ClinicalTrials.gov, on 27 June 2022. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals.

Trial registration number: NCT05433831.

Keywords: nutrition & dietetics; nutritional support; ultrasound.