CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

Completed

• Conditions: COVID-19

• Registration Number: NCT04351802
• Lead Sponsor: University Hospital Plymouth NHS Trust

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).

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-17
• Study Start: 2020-05-11
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Derriford Hospital; 🇬🇧 Plymouth, Devon, United Kingdom