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Muscular DiseasesGraycovidNCT04863534

Ultrasound Grayscale Analysis in ARDS covid19

An observational study of Muscular Diseases and COVID-19 Acute Respiratory Distress Syndrome, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Ultrasound
Type of treatment
Medical device
How many people
32 participants
Where
1 siteItaly
Study dates
1 Apr 2020to 21 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Child, Adult, Older adult

Study population: Ards covid19 icu patients

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • ASST-Santi Paolo e Carlo, San Paolo Hospital

    Milan, 20142

Other trials in Italy

About this study

Official title: 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

Read the 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

Being tested
Ultrasound
Keywords
Ards, Covid 19, Muscular ultrasound
Medical subject headings
Muscular Diseases, Acute Lung Injury, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Muscular grayscale ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grayscale and mortality

    assess if the muscular grayscale of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients influenced the outcomes

    Measured: One year

Secondary outcomes (1)
  1. 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

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start1 Apr 2020
  3. Primary completion21 Feb 2021
  4. Study completion21 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04863534
Sponsor's protocol ID
Umilan1
Acronym
Graycovid
Status last verified
Apr 2021
First submitted
22 Apr 2021
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Muscular Diseases and COVID-19 Acute Respiratory Distress Syndrome, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grayscale and mortality (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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