COVID-19
Conditions
Keywords
COVID-19, Lung Ultrasound
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.
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).
Interventions
DIAGNOSTIC_TESTLung ultrasound
Focused lung ultrasound examination
Sponsors
University Hospital Plymouth NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Suspected or confirmed diagnosis of COVID-19 * Able to provide informed consent to study participation
Exclusion criteria
* Age less than 18 years * Inability to provide informed consent at the time of study enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed