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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513210
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jakub Antczak, Jagiellonian University

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.

Condition or disease
Covid19

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Ultrasound

Group/Cohort
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.



Primary Outcome Measures :
  1. Relation of changes in ultrasound and progression to respiratory failure [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  2. Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection [ Time Frame: Through study completion, an average of 1 year. ]
    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.


Secondary Outcome Measures :
  1. Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  2. Sensitivity of ultrasound in detecting interstitial changes in the lungs [ Time Frame: Through study completion, an average of 1 year. ]
    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.

  3. Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection [ Time Frame: Through study completion, an average of 1 year. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513210


Locations
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Poland
Jagiellonian University Medical College, Department of Neurology
Kraków, Poland, 31503
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Jakub M Antczak, MD Jagiellonian University
Additional Information:
Publications:
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Responsible Party: Jakub Antczak, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT04513210    
Other Study ID Numbers: JagiellonianU67
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Saved ultrasound and computer tomography data, scores of particular ultrasound investigations, volumetric calculations conducted on acquired computer tomography imaging and the records from inpatients and outpatients clinics of University Hospital in Cracow, containing clinical and laboratory data will be available on request sent per e-mail.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection