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Trial registered on ANZCTR


Registration number
ACTRN12616000361404
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
21/03/2016
Date last updated
13/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between lung ultrasound and chest X-ray for the diagnosis of pneumonia in a paediatric emergency department.
Scientific title
Lung ultrasound for the diagnosis of pneumonia in a paediatric emergency department: a diagnostic accuracy study with comparison to chest X-ray.
Secondary ID [1] 288748 0
None
Universal Trial Number (UTN)
U1111-1180-7337
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 297992 0
Condition category
Condition code
Respiratory 298147 298147 0 0
Other respiratory disorders / diseases
Infection 298148 298148 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients for whom a CXR has been ordered to confirm or exclude pneumonia will be identified in the emergency department. The patient's doctor will be approached to determine exclusion criteria and then the parent/guardian will be approached for consent. The informed consent process will include provision of a plain language statement. Children >12 years will be given the option to consent in addition to their parent/guardian.

A lung ultrasound will be performed within 12 hours of the CXR and these LUS findings will be recorded. The lung ultrasound will take approximately 10 minutes and will follow a protocol covering upper and lower zones of the anterior, lateral and posterior chest. Both sagittal/longitudinal and transverse/oblique views will be performed in all 6 lung zones of each hemithorax.

The treating doctor will complete a survey of the patient's clinical features as well as their interpretation of the CXR. From the patient's medical records the following information will be obtained: the radiologist's CXR report, the discharge diagnosis, whether the patient was admitted at their first visit and whether antibiotics were prescribed. A follow-up phone call will be performed 2-3 weeks after the lung ultrasound to determine patient outcomes: admission to hospital, the prescription of antibiotics and patient adherence, further CXRs performed, and further GP and ED attendances and the reasons for attendance. The follow up call will take less than 10 minutes.
Intervention code [1] 294182 0
Diagnosis / Prognosis
Comparator / control treatment
The lung ultrasound findings will be compared to the chest X-ray findings for each patient.
Control group
Active

Outcomes
Primary outcome [1] 297658 0
The diagnostic accuracy of lung ultrasound (index test) for the diagnosis of pneumonia will be measured in sensitivity, specificity, positive likelihood ratio and negative likelihood ratio. Chest X-ray will be the reference test against which lung ultrasound is compared.

A lung ultrasound (LUS) scan will be positive for pneumonia if it has subpleural consolidation with air bronchograms in one or more lung views. This finding must be agreed upon by the sonographer and a blinded reviewer. Is there is disagreement, a final reading will be determined by an independent reviewer.

A chest X-ray (CXR) reading will be provided by the treating clinician based on their standard practice. The CXR report will be positive for pneumonia if it is positive for any of consolidation, interstitial infiltrates or pleural effusion. A positive or negative reading of the CXR must be agreed upon by the treating emergency doctor and the radiologist's report. If there is disagreement, or if either reading is indeterminate, a final reading will be determined by an independent radiologist.
Timepoint [1] 297658 0
At the time of LUS and CXR.
Primary outcome [2] 297659 0
The diagnostic accuracy of lung ultrasound for the diagnosis of pneumonia will be measured in sensitivity, specificity, positive likelihood ratio and negative likelihood ratio, where a LUS is positive if it has subpleural consolidation >1cm with air bronchograms in one or more lung views. This finding must be agreed upon by the sonographer and a blinded reviewer. If there is disagreement, a final reading will be determined by an independent reviewer.
The chest X-ray reference standard will be determined as in Primary outcome [1].
Timepoint [2] 297659 0
At the time of LUS and CXR.
Primary outcome [3] 297660 0
The diagnostic accuracy of lung ultrasound for the diagnosis of pneumonia will be measured in sensitivity, specificity, positive likelihood ratio and negative likelihood ratio.
LUS scans will be positive as defined in primary outcome [1] and will be included if >75% complete and have a sagittal/longitudinal view for every lung zone.
The chest X-ray finding will be determined as in Primary outcome [1].
Timepoint [3] 297660 0
At the time of LUS and CXR.
Secondary outcome [1] 321731 0
The LUS and CXR features associated with CXR-positive/LUS-negative, CXR-positive/LUS-positive, CXR-negative/LUS-negative and CXR-negative/LUS-positive groups will be described.
LUS features will be described in terms of subpleural consolidation >1cm, subpleural consolidation <=1cm, air bronchograms, B lines, pleural line abnormalities and pleural effusion.
The CXR features will be described as consolidation, infiltrates and pleural effusion and whether any consolidation is perihilar.
Timepoint [1] 321731 0
At the time of LUS and CXR.
Secondary outcome [2] 321732 0
The LUS features will be described for any patients who were not diagnosed with pneumonia by their treating doctor at the time of enrolment, but progress to pneumonia (diagnosed at re-attendance) or appear to progress to pneumonia. These patients will be identified by follow-up phone calls to parents/guardians.
Timepoint [2] 321732 0
At 2 - 3 weeks after the LUS in the emergency department.
Secondary outcome [3] 321733 0
The inter-rater reliability of both LUS and CXR will be measured. For LUS, the kappa correlation statistic will measure the correlation between the LUS reading by the sonographer and the LUS reading provided by the reviewer, an emergency physician experienced in point-of-care ultrasound.

A LUS will be considered positive for pneumonia if it has subpleural consolidation with air bronchograms in one or more lung views. For CXR, the kappa correlation statistic will measure the correlation between the CXR reading provided by the treating doctor and that of the attending radiologist's report. The treating doctor will provide their reading based on their standard practice. For the radiologist's report, a CXR will be positive for pneumonia if it is positive for any of consolidation, interstitial infiltrates or pleural effusion.
Timepoint [3] 321733 0
At the time of LUS and CXR.

Eligibility
Key inclusion criteria
1. A CXR has been ordered by the treating doctor or emergency department staff member to confirm or exclude pneumonia.
Minimum age
1 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children <1 month or >18 years at the time of enrolment.
2. Children who arrive to the emergency department with a CXR already taken for their current illness eg ordered by their GP.
3. Children who are receiving CPR, ventilation or other life support interventions.
4. Consent not given.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
All primary outcomes will be reported as sensitivity, specificity and positive and negative likelihood ratios, each reported with a 95% confidence interval.
The secondary outcomes relating to LUS and CXR features will be descriptive in nature.
Kappa correlation statistics will be used to assess inter-rater reliability between novice sonographers and experienced reviewers for LUS; and between treating doctors' and radiologists' reports for CXR.
As this is a diagnostic accuracy study and not a randomised study comparing two study arms, a power calculation is not applicable. The sample size of 80-100 participants was determined by what was deemed feasible based on the number of CXRs performed over similar dates in 2015. In addition, the width of the 95% confidence interval found in similar studies with a similar sample size was considered.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2016
Actual
22/03/2016
Date of last participant enrolment
Anticipated
5/06/2016
Actual
5/06/2016
Date of last data collection
Anticipated
Actual
19/06/2016
Sample size
Target
100
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5430 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 12915 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 293106 0
Self funded/Unfunded
Name [1] 293106 0
None
Country [1] 293106 0
Primary sponsor type
Hospital
Name
Emergency Department - The Royal Children's Hospital
Address
The Royal Children's Hospital
50 Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 291896 0
None
Name [1] 291896 0
None
Address [1] 291896 0
None
Country [1] 291896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294607 0
RCH Human Research Ethics Committee (HREC)
Ethics committee address [1] 294607 0
Ethics committee country [1] 294607 0
Australia
Date submitted for ethics approval [1] 294607 0
10/03/2016
Approval date [1] 294607 0
18/03/2016
Ethics approval number [1] 294607 0
35272B

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

Contacts
Principal investigator
Name 64334 0
Dr Adam O'Brien
Address 64334 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
3052
Victoria
Country 64334 0
Australia
Phone 64334 0
+61 3 9345 9825
Fax 64334 0
Email 64334 0
adam.obrien@rch.org.au
Contact person for public queries
Name 64335 0
Adam O'Brien
Address 64335 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
3052
Victoria
Country 64335 0
Australia
Phone 64335 0
+61 3 9345 9825
Fax 64335 0
Email 64335 0
adam.obrien@rch.org.au
Contact person for scientific queries
Name 64336 0
Adam O'Brien
Address 64336 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville
3052
Victoria
Country 64336 0
Australia
Phone 64336 0
+61 3 9345 9825
Fax 64336 0
Email 64336 0
adam.obrien@rch.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseProspective observational study of point-of-care ultrasound for diagnosing pneumonia.2019https://dx.doi.org/10.1136/archdischild-2017-314496
N.B. These documents automatically identified may not have been verified by the study sponsor.