Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity of Covid-19 Infection

NCT04513210 | Completed

• 1 other identifier: JagiellonianU67
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound can reliably detect morphologic changes associated with pneumonia. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of long-term pulmonary complications as consequences of Covid-19 pneumonia.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Relation of changes in ultrasound and progression to respiratory failure

  Comparison of percentage of patients with oxygenation index drop below 300 mmHg during 14 after inclusion between group with and without changes in the ultrasound on admission.

  Through study completion, an average of 1 year.

• Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection

  Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group with signs of pneumonia vs. group without signs of pneumonia in the ultrasound, on the day of admission.

  Through study completion, an average of 1 year.

Secondary Outcomes (3)

• Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure

  Through study completion, an average of 1 year.

• Sensitivity of ultrasound in detecting interstitial changes in the lungs

  Through study completion, an average of 1 year.

• Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection

  Through study completion, an average of 1 year.

Study Arms (2)

Changes in the lungs on admission

Patients with Covid-19 infection admitted to the University Hospital with changes in the ultrasound on admission, suggesting pneumonia.

No changes in the lungs on admission

Patients with Covid-19 infection admitted to the University Hospital without changes in the ultrasound on admission, suggesting pneumonia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who will be admitted to the University Hospital in Cracow (Poland) due to Covid-19 infection. University Hospital is one of the largest hospitals in Poland, erving approximately 4,5 million inhabitants of southern Poland.

You may qualify if:

• Patients sufficiently medically ill to require hospital admission.

You may not qualify if:

• Interstitial lung disease in the past.
• Chronic respiratory insufficiency.
• Significant bronchial obstruction n the day of admission to the University Hospital.
• Pulmonary embolism during three months before admission.
• Significant thorax deformity, which may disturb the investigation of the lungs with ultrasound.
• Hemodynamic instability
• Pregnancy (relative contraindication for computer tomography)

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Neurology

Krakow, 31503, Poland

Location

Related Publications (6)

• Liu J, Liu F, Liu Y, Wang HW, Feng ZC. Lung ultrasonography for the diagnosis of severe neonatal pneumonia. Chest. 2014 Aug;146(2):383-388. doi: 10.1378/chest.13-2852.

  PMID: 24833216 BACKGROUND

• Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.

  PMID: 22700780 BACKGROUND

• Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15.

  PMID: 32239532 BACKGROUND

• Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.

  PMID: 32053470 BACKGROUND

• Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.

  PMID: 32105637 BACKGROUND

• Chrzan R, Polok K, Antczak J, Siwiec-Kozlik A, Jagiello W, Popiela T. The value of lung ultrasound in COVID-19 pneumonia, verified by high resolution computed tomography assessed by artificial intelligence. BMC Infect Dis. 2023 Mar 31;23(1):195. doi: 10.1186/s12879-023-08173-4.

  PMID: 37003997 DERIVED

Related Links

• This link refers to the site of the World Health Organization reporting the current epidemiological situation of Covid-19

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jakub M Antczak, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: October 10, 2020
• Primary Completion: March 7, 2022
• Study Completion: April 5, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

PL (1)