Muscular Ultrasound and Production of ICUAW

NCT04864093 | Completed

• 1 other identifier: Umilan@
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Skeletal muscle weakness is a common complication of acute respiratory failure, shock and other manifestations of critical illness or injury. ICU acquired weakness (ICUAW) - an entity defined as a bundle of critically illness neuro-myopathy and disuse atrophy - is generally diagnosed on the basis of a volitional, clinical strength evaluation, which however requires patient cooperation and ability to comprehend the assessor's instructions. As patients are often unconscious or uncooperative, due to sedation or delirium, such clinical diagnosis is often not possible or is delayed. A further subclassification of critical illness neuromyopathy can be achieved using detailed nonvolitional electrophysiological investigations, which can be challenging in the ICU as they require skilled personnel for both assessment and interpretation. An average Medical Research Council strength score (MRC-SS) combined for 12 specified muscle groups lower than 48 has been widely used for diagnosing ICUAW. Recent studies reported the clinical applicability of the MRC-SS in a general ICU population, in particular its clinical usefulness in predicting ICU and in-hospital patient outcomes . Moreover, interobserver agreement and clinical predictive value have already been showed (8). However, ICU general population is less likely to be able to cooperate with volitional strength assessment and more likely to have limited access to their extremities because of trauma, burns and treatment involving medical devices. For these reasons, MRC-SS may be confined to the later stages of ICU stay. Skeletal muscle ultrasound is used for the evaluation of muscular, tendon and joint disorders. It allows the evaluation of normal and pathological skeletal muscles through the measure of parameters reflecting size, such as cross sectional area (CSA) , and architecture by calculating the pennation angle, and it allows quick and repeated bedside evaluations. Despite such promising features, to date, there are few published studies that have reported the clinical applicability of the muscle ultrasound in prediction of ICUAW during the ICU stay. The principal aim of this study is to evaluate the variation of peripheral muscle ultrasound characteristics (such as CSA and pennation angle) during the ICU stay and its possible early predictive value of ICUAW as compared to the MRC-SS performed when patients are able to cooperate.

Conditions

Weakness, Muscle

Outcome Measures

Primary Outcomes (1)

• muscular reduction over the time

  Muscular ultrasound detect a muscles reduction over the time

  One year

Secondary Outcomes (1)

• muscular ultrasond predictivity of ICUAW

  One year

Interventions

muscular ultrasound DIAGNOSTIC_TEST

respiratroy and muscular ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all ICU patients

You may qualify if:

• patients admitted to ICU witha prediction of ICU stay \>7 days

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST Santi Paolo carlo

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 28, 2021
• Study Start: January 21, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)