Ultrasound Grayscale Analysis in ARDS covid19

NCT04863534 | Completed

• 1 other identifier: Umilan1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Muscular Diseases; COVID-19 Acute Respiratory Distress Syndrome

Keywords

Ards; Covid 19; Muscular ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Grayscale and inflammation

  One year

Interventions

Ultrasound DEVICE

Muscular grayscale ultrasound

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ards covid19 icu patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST-Santi Paolo e Carlo, San Paolo Hospital

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Muscular Diseases; Acute Lung Injury; COVID-19

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

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: April 1, 2020
• Primary Completion: February 21, 2021
• Study Completion: February 21, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)