COR-DLUS: CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
Study Details
Study Description
Brief Summary
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.
Participants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.
Participants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).
Study Design
Outcome Measures
Primary Outcome Measures
- Diagnosis of COVID-19 on lung ultrasound [On day of admission to hospital]
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound
- Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray [On day of admission to hospital]
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings
Secondary Outcome Measures
- Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray [On day of admission to hospital]
Primary and blinded scorer diagnosis of alternative condition on lung ultrasound
- Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19 [During hospital admission]
Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirements
- Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19 [On day of admission to hospital]
Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age greater than or equal to 18 years
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Suspected or confirmed diagnosis of COVID-19
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Able to provide informed consent to study participation
Exclusion Criteria:
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Age less than 18 years
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Inability to provide informed consent at the time of study enrolment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Derriford Hospital | Plymouth | Devon | United Kingdom | PL6 8DH |
Sponsors and Collaborators
- University Hospital Plymouth NHS Trust
Investigators
- Principal Investigator: John P Corcoran, BMBCh MRCP, University Hospitals Plymouth NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 282661