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.
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
- Conditions the study is for
- Muscular Diseases, COVID-19 Acute Respiratory Distress Syndrome
- 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.
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.
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)
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.
- First posted28 Apr 2021
- Study start1 Apr 2020
- Primary completion21 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, University of Milan
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Muscular Ultrasound in covid19 ARDS Patients
- ClinicalTrials.gov ID
- NCT04863534
- Acronym / sponsor ID
- Graycovid / Umilan1
- Keywords
- Ards, Covid 19, Muscular ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Ards covid19 icu patients
Key inclusion criteria (1 listed)
- intubated patients with confirmed infection by SARS COV 2 and diagnosis of ARDS
Key exclusion criteria (1 listed)
- age less than 18 years, history of severe chronic obstructive pulmonary disease, pregnancy, failure to perform respiratory muscle ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundMuscular grayscale ultrasound | Device | – |
Primary outcome
Grayscale and mortality
Time frame: One year
assess if the muscular grayscale of parasternal intercostal, diaphragm and quadriceps muscles of ICU COVID19 patients influenced the outcomes
1 secondary outcome
Grayscale and inflammation
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Muscular Diseases
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
Enrolling by invitationObservational study
Personalized Disease Modeling for Rare Genetic Myopathies
Congenital Myopathies, Muscular Dystrophy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Transcriptomic Analysis to Put an End to Misdiagnosis in Patients With Rare Muscle Diseases
Rare Genetic Muscle Diseases, Muscular Dystrophy, Duchenne
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.