Ultrasound Grayscale Analysis in ARDS covid19 (Graycovid)

Qualitative Muscular Ultrasound in covid19 ARDS Patients

Recent evidence regarding the novel coronavirus disease 2019 (COVID19) is growing in describing the characteristics of this disease, with main focus on lung morphology. Few data are available regarding the peripheral and respiratory muscular characteristics. Using a ultrasound greyscale analysis, It Is possibile to evaluated the muscle quality.

The hypothesis of this studi is that a combined assessment of respiratory (i.e., intercostal and diaphragm) and peripheral (i.e., quadriceps) muscles quantity (as measured by thickness) and quality (as assessed by greyscale analysis), would reflect the severity of illness. Thus,the aims of this study are to assess if the quality characteristics of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients influenced the outcomes and are correlated with other variables, such as fluid or protein balance, or indexes of inflammation

Study Overview

• Status: Completed
• Conditions: Muscular Diseases; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Ultrasound

Detailed Description

Up to 30% of the patients affected by the novel coronavirus disease 2019 (COVID19) may develop an acute respiratory distress syndrome (ARDS), which requires in the majority of patients a respiratory support with non-invasive mechanical ventilation and, very often, the intubation . Recent evidence is growing in describing the characteristics of this disease, with main focus on lung morphology. Therapeutic strategies implemented for their management may often lead to short-term muscular and functional alterations resulting in ICU-Acquired weakness. These lead to long-term disabilities expressing through dependence and quality of life impairment of survivors. Indeed, few data are still available regarding the peripheral and respiratory muscular characteristics, mainly because this investigation is usually confined in more advance stages of disease. Muscular ultrasonography allows visualization and classification of muscle characteristics which may be described besides muscles' thickness with their echogenicity. In fact, lean muscle tissue has a low echogenicity, whereas intramuscular fat and connective tissue are characterized by a high echogenicity.

Using a greyscale analysis, the total muscle echo-intensity may in fact be quantified. The assumption is that the higher the mean pixel intensity of a muscle region of interest, the lower the muscle quality (i.e., more intramuscular fat or connective tissue) and thus its inhomogeneity. Muscle echogenicity has already been investigated during critical illness, although its modifications over the time and its associated histopathological characteristics remain to be determined. In fact, inflammation and infection as well as fluid shifts may substantially contribute to the increment in muscular inhomogeneity. Few data are available regarding the characteristics of respiratory muscle ultrasound quality during critical illness, as most of the study restricted this methodology to the analysis of peripheral muscles in the detection of ICU acquired weakness. Recently, the parasternal intercostal muscles and the diaphragm have been investigated together in the critical care setting as they represent the easiest accessible respiratory muscles to be investigated by ultrasound .

The investigators hypothesized that a combined assessment of respiratory (i.e., intercostal and diaphragm) and peripheral (i.e., quadriceps) muscles quantity (as measured by thickness) and quality (as assessed by greyscale analysis), would reflect the severity of illness. Thus,the aims of this study are to assess if the quality characteristics of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients influenced the outcomes and are correlated with other variables, such as fluid or protein balance, or indexes of inflammation

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20142
    • ASST-Santi Paolo e Carlo, San Paolo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Ards covid19 icu patients

Description

Inclusion Criteria:

- intubated patients with confirmed infection by SARS COV 2 and diagnosis of ARDS

Exclusion Criteria:

• age less than 18 years, history of severe chronic obstructive pulmonary disease, pregnancy, failure to perform respiratory muscle ultrasound

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grayscale and mortality	assess if the muscular grayscale of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients influenced the outcomes	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grayscale and inflammation	assess if the muscular grayscale characteristics of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients are correlated with other variables, such as fluid or protein balance, or indexes of inflammation	One year

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): February 21, 2021
• Study Completion (Actual): February 21, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Covid 19; Ards; Muscular ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Muscular Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Umilan1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No