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

Covid19 Clinical Trial

Official title:

Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity, Length of Hospitalization and Long-term Complications and of Covid-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513210
• Other study ID #: JagiellonianU67
• Status: Completed
• Start date: October 10, 2020
• Est. completion date: April 5, 2023

Study information

• Verified date: June 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Covid-19 pneumonia became the worldwide, serious health problem, affecting nearly 20 million people and causing nearly one million deaths. The health systems of many countries are overwhelmed with the increased need of medical care, of the number of available hospital beds, intensive care beds and ventilators. The proper management of available resources becomes now critical. Ultrasound can reliably detect morphologic changes associated with pneumonia, especially in Covid-19 pneumonia, where the involvement of superficial parts of the lungs predominates. 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. Finally, it is much easier to take measures, which minimize the risk of viral transmission between patients for ultrasound equipment than for other lung imaging devices such as x-ray or computer tomography. 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 the long-term pulmonary complications as consequences of Covid-19 pneumonia. The study will include repeated ultrasound investigations in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients admitted to the University Hospital in Cracow (Poland) performed during hospitalization and after discharge. The relation of severity and the course of pneumonia revealed by ultrasound to clinical condition, long term complications, use of mechanical ventilation, admission to intensive care and results of laboratory tests will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 5, 2023
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients sufficiently medically ill to require hospital admission.

• Confirmed SARS-CoV-2 infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample not earlier than five days prior to inclusion.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Neurology	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure	Correlation of the score reflecting severity of ultrasonographic pneumonia signs with oxygen saturation of arterial blood and with oxygen and carbon dioxide partial pressure in repetitive measurements.	Through study completion, an average of 1 year.
Secondary	Sensitivity of ultrasound in detecting interstitial changes in the lungs	Correlation of the score reflecting severity of ultrasonographic pneumonia signs with the volume of lung interstitium affected by pneumonia, measured in high resolution computer tomography scans.	Through study completion, an average of 1 year.
Secondary	Impact change in severity of ultrasonographic pneumonia signs 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 which improved and which did not improve in the score reflecting severity of ultrasonographic pneumonia signs from the measurement on the day of admission to measurement five days later.	Through study completion, an average of 1 year.

External Links

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