ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Composite outcome of death, intubation or ICU admission, as per the medical record

Timepoint [1]

This is defined as the patient reaching any of these outcomes prior to the end of their hospital admission.

Secondary outcome [1]

Hospital length of stay, as per medical record.

Timepoint [1]

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]

Duration of admission to the Intensive Care Unit (or High Dependency Unit), as per the medical record

Timepoint [2]

This is defined as the total time from admission to the ICU/HDU, until discharge from ICU/HDU or death.

Secondary outcome [3]

Duration of invasive ventilation during hospital admission, as per the medical record

Timepoint [3]

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]

Duration of non-invasive ventilation during hospital admission, as per the medical record

Timepoint [4]

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]

Clinical features of patients will be recorded from the medical record, including vital signs and respiratory support/oxygenation

Timepoint [5]

This data will be prospectively collected cross-sectionally at the time the patient receives their LUS in the emergency department

Secondary outcome [6]

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]

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]

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]

This data will be prospectively collected cross-sectionally at the time the patient receives their LUS in the emergency department

Secondary outcome [8]

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]

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?

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]

3168 - Clayton

Recruitment postcode(s) [2]

3175 - Dandenong

Recruitment postcode(s) [3]

4215 - Southport

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Ottawa and London, Ontario

Country [2]

Canada

State/province [2]

Winnipeg, Manitoba

Country [3]

United States of America

State/province [3]

Buffalo, New York

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Hospital

Address [1]

246 Clayton Rd, Clayton, Vic 3168

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Hospital

Address

246 Clayton Rd, Clayton, Vic 3168

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Gold Coast University Hospital

Address [1]

1 Hospital Blvd, Southport, Qld, 4215

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services Monash Health
Level 2, I Block
Monash Medical Centre 246 Clayton Road
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/07/2020

Ethics approval number [1]

RES-20-0000-284A / ERM63309

Summary

Brief summary

Lung ultrasound (LUS) is known to be more sensitive for detection of lung pathology compared to plain radiography and comparable to computerised tomography (CT), particularly for peripheral or pleurally based lesions.  For example, it can be used in diagnosing interstitial patterns including pulmonary edema, as well as consolidation and effusions.   Point-of-care (POCUS) is readily available in most emergency departments (ED), where it can immediately supply clinical information at the bedside. 

SARS-CoV-2 viral pneumonia (COVID-19) has led some practitioners to assess if LUS has  utility in its diagnosis or prognosis.  There are specific findings which represent viral pneumonias, such as increasing density of B-lines, subpleural consolidations, and absence of pleural effusions.  Unfortunately LUS is currently unable to distinguish COVID-19 from other viral pneumonias but may be possible with further description of findings in a large cohort of patients. Although the current de facto “gold standard” for COVID-19 diagnosis, reverse-transcriptase polymerase chain reaction (RT-PCR) has a delayed turnaround of results and lacks sensitivity, particularly early in the course of the illness.  

Although LUS is unlikely to replace nucleic acid testing for definitive diagnosis, it may have utility in predicting clinical deterioration indicating need for ventilatory support. If proven to be accurately predictive of clinical deterioration, LUS findings could be integrated with clinical findings at the time of ED presentation, to triage patients to either outpatient management (low risk features), ward admission (moderate risk features) or intensive care unit (ICU) admission (high risk features). This could impact patient outcomes, resource allocation, and departmental flow, particularly in times of crisis. Furthermore, the findings from this study may inform the use of LUS in future respiratory virus pandemics.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Gabriel Bletcher

Address

Monash Health Department of Emergency Ground floor
246 Clayton Rd Clayton Vic 3168

Country

Australia

Phone

+61 395946666

Fax

gabriel.blecher@monash.edu

Contact person for public queries

Name

Gabriel Bletcher

Address

Monash Health Department of Emergency Ground floor
246 Clayton Rd Clayton Vic 3168

Country

Australia

Phone

+61 395946666

Fax

gabriel.blecher@monash.edu

Contact person for scientific queries

Name

Peter J Snelling

Address

Gold Coast University Hospital
Emergency Department
1 Hospital Blvd
Southport, Qld 4215

Country

Australia

Phone

+61 1300 744 284

Fax

peter.snelling@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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