Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04863534 |
| Other study ID # |
Umilan1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
February 21, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Milan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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
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
