Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000962336p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2017
Date registered
5/07/2017
Date last updated
5/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-Hospital Lung Ultrasound in Infants Presenting with Respiratory Illness:
A Feasibility Study
Scientific title
Pre-Hospital Lung Ultrasound in Infants Presenting with Respiratory Illness:
A Feasibility Study
Secondary ID [1] 291678 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 302840 0
Pneumonia 302841 0
Condition category
Condition code
Respiratory 302327 302327 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-hospital point-of-care ultrasound of the lungs will be performed by Central Australian Retrieval Doctors at the clinic/remote health centre/site of retrieval prior to transport to Alice Springs Hospital.

The participants will have warmed ultrasound gel applied to four areas on the chest (2 right and 2 left) and bedside ultrasound scanning carried-out. The de-identified images will then be saved and the performing medical officer will record their findings on the study proforma.

The intervention fidelity and any difficulties encountered will be recorded by the performing doctor on the study proforma. If inadequate images are obtained, this will be recorded as such.
Intervention code [1] 297764 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301738 0
Composite primary outcome: To assess the feasibility and practicality of performing lung ultrasound, and obtaining images of adequate diagnostic value, on infants in the pre-hospital setting.
Timepoint [1] 301738 0
The performing Retrieval Doctor will record the findings and diagnosis on the study proforma at the time of the intervention. Any difficulties or practical issues will also be recorded.
Secondary outcome [1] 333710 0
Inter-operator variability of image interpretation and diagnosis (from those images).

This will occur by ultrasonogpraphers interpreting the saved images and recording their diagnosis. The second reading will then be compared to the initial diagnosis to demonstrate whether both parties agree.

The ultrasonographer will be blinded to the initial findings recorded by the performing Retrieval Doctor.
Timepoint [1] 333710 0
This should occur within 24-72 hours of the images being obtained, but could occur at any stage prior to the patient discharge.
Secondary outcome [2] 336578 0
Correlation of pre-hospital US findings with the clinical diagnosis by the paediatric team.
Timepoint [2] 336578 0
On discharge of the patient as recorded in the notes

Eligibility
Key inclusion criteria
Children <18 months of age with symptoms consistent with a respiratory illness, including shortness of breath, increased work of breathing, coryza, fever and/or cough requiring retrieval via the Central Australian Retrieval Service for management in hospital
Minimum age
No limit
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age > 2 years (as per diagnostic criteria for Bronchiolitis)
No symptoms of respiratory illness
Refusal of guardian/parents to assent to study participation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Kappa co-efficient will be calculated for inter-observer variability.

Inter-observer variability of 60% with 20% error rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD,WA
Recruitment hospital [1] 8076 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 16126 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 296174 0
Government body
Name [1] 296174 0
Central Australian Health Network
Country [1] 296174 0
Australia
Primary sponsor type
Government body
Name
Central Australian Health Network
Address
Alice Springs Hospital
Gap Road
Alice Springs
NT. 0870
Country
Australia
Secondary sponsor category [1] 295906 0
None
Name [1] 295906 0
Address [1] 295906 0
Country [1] 295906 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297418 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 297418 0
Ethics committee country [1] 297418 0
Australia
Date submitted for ethics approval [1] 297418 0
29/06/2017
Approval date [1] 297418 0
Ethics approval number [1] 297418 0

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

Contacts
Principal investigator
Name 73982 0
Dr Tecwyn Davies
Address 73982 0
Emergency Department
Alice Springs Hospital
Gap Road
NT. 0870
Country 73982 0
Australia
Phone 73982 0
+61 8 895 17657
Fax 73982 0
Email 73982 0
[email protected]
Contact person for public queries
Name 73983 0
Richard Johnson
Address 73983 0
Emergency Department
Alice Springs Hospital
Gap Road
NT. 0870
Country 73983 0
Australia
Phone 73983 0
+61 8 895 17657
Fax 73983 0
Email 73983 0
[email protected]
Contact person for scientific queries
Name 73984 0
Richard Johnson
Address 73984 0
Emergency Department
Alice Springs Hospital
Gap Road
NT. 0870
Country 73984 0
Australia
Phone 73984 0
+61 8 895 17657
Fax 73984 0
Email 73984 0
[email protected]

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
No additional documents have been identified.