Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000734965
Ethics application status
Approved
Date submitted
6/07/2020
Date registered
13/07/2020
Date last updated
4/08/2022
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung ultrasound to predict invasive ventilation of patients with COVID-19 lung disease
Scientific title
Use of Lung Ultrasound for Diagnosis and Prognostication of patient presented with COVID-19 Lung Disease in the Emergency Department: A prospective observational cohort study
Secondary ID [1] 301069 0
Nil known
Universal Trial Number (UTN)
U1111-1254-7764
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317129 0
Condition category
Condition code
Infection 315286 315286 0 0
Other infectious diseases
Respiratory 316187 316187 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients presenting to the emergency department suspected of having COVID-19, who are admitted to hospital, will have lung ultrasound (LUS) findings recorded and compared against COVID-19 status and outcomes. LUS images will be collected alongside data collected from routine care of patients. For many sites LUS is part of routine care of these patients. Patients will be followed until discharge, for a maximum of 12 months.
Intervention code [1] 317374 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323529 0
Composite outcome of death, intubation or ICU admission, as per the medical record
Timepoint [1] 323529 0
This is defined as the patient reaching any of these outcomes prior to the end of their hospital admission.
Secondary outcome [1] 382168 0
Hospital length of stay, as per medical record.
Timepoint [1] 382168 0
This is defined as the total time from presentation to the emergency department, until the end of the hospital admission (discharge from hospital or death).
Secondary outcome [2] 384401 0
Duration of admission to the Intensive Care Unit (or High Dependency Unit), as per the medical record
Timepoint [2] 384401 0
This is defined as the total time from admission to the ICU/HDU, until discharge from ICU/HDU or death.
Secondary outcome [3] 384402 0
Duration of invasive ventilation during hospital admission, as per the medical record
Timepoint [3] 384402 0
This is defined as the total time a patient is invasively ventilated during this hospital admission, either in the emergency department, inpatient ward or intensive care unit.
Secondary outcome [4] 384403 0
Duration of non-invasive ventilation during hospital admission, as per the medical record
Timepoint [4] 384403 0
This is defined as the total time a patient is non-invasively ventilated during this hospital admission, either in the emergency department, inpatient ward or intensive care unit.
Secondary outcome [5] 384404 0
Clinical features of patients will be recorded from the medical record, including vital signs and respiratory support/oxygenation
Timepoint [5] 384404 0
This data will be prospectively collected cross-sectionally at the time the patient receives their LUS in the emergency department
Secondary outcome [6] 384405 0
Lung features will be assessed of any other imaging, such as chest x-ray or chest CT, arranged as part of routine care of the patient
Timepoint [6] 384405 0
This data will be prospectively collected cross-sectionally at the time the patient receives their LUS in the emergency department, within a window of up to 3 hours.
Secondary outcome [7] 384406 0
Description of LUS findings for a 12-zone scanning protocol of patients admitted with COVID-19 disease. This will include any pleural and parenchymal abnormalities and their distribution. We will explore any LUS findings that are specific to a diagnosis of COVID-19
Timepoint [7] 384406 0
This data will be prospectively collected cross-sectionally at the time the patient receives their LUS in the emergency department
Secondary outcome [8] 384407 0
Diagnostic test characteristics (sensitivity, specificity, positive and negative likelihood ratios) for LUS diagnosis of COVID-19, with incorporation of disease prevalence in that geographic location at the time of admission. The criterion standard will be final discharge diagnosis as determined from the medical record.
Timepoint [8] 384407 0
This is defined as the patient's final COVID-19 status at the end of their hospital admission.

Eligibility
Key inclusion criteria
Patients aged 18 years or older who:

Present to the emergency department with suspected or confirmed COVID-19 disease, who have been swabbed (either in the ED or prior to attending ED)
Are being admitted with suspected or proven diagnosis of COVID-19
Have a lung ultrasound performed by credentialed provider in the ED
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient already enrolled in the current study
Patient deemed for palliative/comfort care approach
Lung US images not recorded, or inadequate, for review
Prior pneumonectomy or other significant pre-existing lung pathology or treatment e.g. malignancy, pleurodesis, fibrosis.
Patient unable to provide consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be performed for the cohort to determine prognostication of LUS for COVID-19.

Subgroup analysis
Age <50 years and age >50 years will be analysed as pre-specified subgroups.
Findings associated with time delay from symptom onset to image acquisition
Other imaging - CXR/ CT/ portable CXR comparisons
Ultrasound machine model
Comorbidities
Geographic location with current disease prevalence
Level of respiratory support


Multivariate analysis of patient demographics and lung ultrasound findings as risk factors for primary and secondary outcomes.

Secondarily, the diagnostic characteristics of LUS for COVID-19 may be determined for individual sites with adequate data, and will account for the different disease prevalence in that region (affects pre-test probability). This will include sensitivity, specificity, predictive values, and likelihood ratios.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
13/07/2020
Actual
9/08/2020
Date of last participant enrolment
Anticipated
31/03/2022
Actual
14/04/2022
Date of last data collection
Anticipated
30/04/2022
Actual
14/04/2022
Sample size
Target
1000
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 30045 0
3168 - Clayton
Recruitment postcode(s) [2] 30047 0
3175 - Dandenong
Recruitment postcode(s) [3] 30690 0
4215 - Southport
Recruitment outside Australia
Country [1] 22717 0
Canada
State/province [1] 22717 0
Ottawa and London, Ontario
Country [2] 22718 0
Canada
State/province [2] 22718 0
Winnipeg, Manitoba
Country [3] 22720 0
United States of America
State/province [3] 22720 0
Buffalo, New York

Funding & Sponsors
Funding source category [1] 306132 0
Hospital
Name [1] 306132 0
Monash Hospital
Country [1] 306132 0
Australia
Primary sponsor type
Hospital
Name
Monash Hospital
Address
246 Clayton Rd, Clayton, Vic 3168
Country
Australia
Secondary sponsor category [1] 305911 0
Hospital
Name [1] 305911 0
Gold Coast University Hospital
Address [1] 305911 0
1 Hospital Blvd, Southport, Qld, 4215
Country [1] 305911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305821 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305821 0
Ethics committee country [1] 305821 0
Australia
Date submitted for ethics approval [1] 305821 0
Approval date [1] 305821 0
02/07/2020
Ethics approval number [1] 305821 0
RES-20-0000-284A / ERM63309

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101718 0
Dr Gabriel Bletcher
Address 101718 0
Monash Health Department of Emergency Ground floor
246 Clayton Rd Clayton Vic 3168
Country 101718 0
Australia
Phone 101718 0
+61 395946666
Fax 101718 0
Email 101718 0
[email protected]
Contact person for public queries
Name 101719 0
Gabriel Bletcher
Address 101719 0
Monash Health Department of Emergency Ground floor
246 Clayton Rd Clayton Vic 3168
Country 101719 0
Australia
Phone 101719 0
+61 395946666
Fax 101719 0
Email 101719 0
[email protected]
Contact person for scientific queries
Name 101720 0
Peter J Snelling
Address 101720 0
Gold Coast University Hospital
Emergency Department
1 Hospital Blvd
Southport, Qld 4215
Country 101720 0
Australia
Phone 101720 0
+61 1300 744 284
Fax 101720 0
Email 101720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Extended consent not approved


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.