Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001973202
Ethics application status
Approved
Date submitted
1/12/2018
Date registered
6/12/2018
Date last updated
12/03/2020
Date data sharing statement initially provided
6/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehospital eFAST performance: a retrospective review of prospectively collected data
Scientific title
Prehospital eFAST performance: a retrospective review of prospectively collected data
Secondary ID [1] 296759 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 310643 0
Condition category
Condition code
Emergency medicine 309357 309357 0 0
Resuscitation
Public Health 309392 309392 0 0
Health service research
Injuries and Accidents 309393 309393 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To investigate the accuracy of prehospital eFAST (extended-Focussed Assessment with Sonography for Trauma) ultrasound interpretation when performed by prehospital and retrieval physicians.

This study will retrospectively review, prospectively recorded ultrasound data (electronic health database) by an Australian HEMS service. Participants underwent their ultrasound as a component for prehospital critical care (including diagnostics and treatment) prior to arrival at a major trauma centre. The duration of observation for each participant was that dictated by their subsequent hospital admission.
Intervention code [1] 313070 0
Diagnosis / Prognosis
Comparator / control treatment
1. In-hospital eFAST scan
2. In-hospital CT scan
3. Intra-operative findings
Control group
Active

Outcomes
Primary outcome [1] 308313 0
The accuracy of the prehospital eFAST scan interpretation for intraperitoneal free fluid and pneumothorax against either CT imaging of chest/abdomen or intraoperative findings within four hours of hospital arrival as measured by McNemar’s test.
Timepoint [1] 308313 0
4 hours post-arrival to hospital
Secondary outcome [1] 354597 0
Accuracy of prehospital eFAST interpretation versus in-hospital arrival eFAST by a trauma team member, as measured by McNemar’s test where a true positive is presence of the same finding on prehospital and arrival eFAST scan.
Timepoint [1] 354597 0
1 hour post-arrival to hospital
Secondary outcome [2] 354598 0
Accuracy of other prehospital eFAST findings (haemothorax and pericardial fluid) compared to hospital eFAST, CT imaging or operative findings, as measured by McNemar’s test.
Timepoint [2] 354598 0
4 hours post-arrival to hospital
Secondary outcome [3] 354599 0
Accuracy of prehospital eFAST interpretations between GSA-HEMS consultants and registrars, as measured by Chi-Sq test.
Timepoint [3] 354599 0
4 hours post-arrival to hospital
Secondary outcome [4] 354600 0
Percent of prehospital interventions which are performed based on prior ultrasound findings (eg. thoracostomy for detected pneumothorax).

Assessed by two independent HEMS physicians with advanced qualifications in point-of=care ultrasound (Certificate of Clinician Performed Ultrasound) who will review each individual casesheet and database entry for evidence of prehospital intervention performed after the influence of prehospital ultrasound scan.
Timepoint [4] 354600 0
4 hours post-arrival to hospital

Eligibility
Key inclusion criteria
- Adults (aged greater than or equal to 16 years) with a reported traumatic mechanism of injury.
- Prehospital contact with GSA-HEMS physician-paramedic team.
- Prehospital eFAST ultrasound recorded in AirMaestro database.
- Transported to Liverpool or Westmead Major Trauma Centres in NSW.
- CT scan or surgery within four hours of hospital arrival.
- ISS greater than or equal to 12.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who died prior to arriving at the destination hospital
- Patients who did not undergo definitive imaging (eFAST, CT) or undergo
surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Demographics, ultrasound details, physiological observations, clinical interventions and in-hospital results will be reported as descriptive statistics. All analyses will be supervised by a senior biostatistician. Normally distributed outcomes will be reported as means (SD) and non-normal data will be reported as medians (IQR). Categorical data will be reported as count and proportions. As we will be conducting three hypothesis tests on the accuracy of E-FAST two-sided p-value of 0.05 will be considered statistically significant.

The accuracy of prehospital eFAST will be compared to its in-hospital gold standard using McNemar’s test. Three comparisons will be performed, one for intraperitoneal free fluid, the other for pneumothorax, and finally for combined outcome of pericardial fluid or haemothorax. As we will be conducting three hypothesis tests on the accuracy of E-FAST, a bonferroni corrected two-sided p-value of 0.17 ((0.05 /3) will be considered statistically significant. If the sample size is not met, then a composite score will be created, combining true positives of intraperitoneal fluid, pneumothorax, haemothorax and pericardial free fluid to a single “E-FAST positive score” for prehospital FAST to the inhospital gold standard.
To compare the accuracy of prehospital FAST between consultants and registrars, the composite score of E-FAST positive outlined above will be used in a 2x2 table and analysed with Chi-Sq test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2018
Actual
10/12/2018
Date of last participant enrolment
Anticipated
1/01/2019
Actual
17/02/2020
Date of last data collection
Anticipated
1/03/2019
Actual
17/02/2020
Sample size
Target
500
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12615 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 12616 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 25033 0
2170 - Liverpool
Recruitment postcode(s) [2] 25034 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 301338 0
Government body
Name [1] 301338 0
NSW Ambulance (Greater Sydney Area HEMS)
Country [1] 301338 0
Australia
Primary sponsor type
Government body
Name
NSW Ambulance (Greater Sydney Area HEMS)
Address
33 Nancy Ellis Leebold Dr
Bankstown Aerodrome NSW 2200
Country
Australia
Secondary sponsor category [1] 301005 0
None
Name [1] 301005 0
Address [1] 301005 0
Country [1] 301005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302078 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 302078 0
Ethics committee country [1] 302078 0
Australia
Date submitted for ethics approval [1] 302078 0
05/06/2018
Approval date [1] 302078 0
15/06/2018
Ethics approval number [1] 302078 0
LNR/18/POWH/262

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

Contacts
Principal investigator
Name 89050 0
Dr Christopher Partyka
Address 89050 0
Greater Sydney Area HEMS (NSW Ambulance)
33 Nancy Ellis Leebold Drive
Bankstown Airport NSW 2200
Country 89050 0
Australia
Phone 89050 0
+61 410585798
Fax 89050 0
Email 89050 0
[email protected]
Contact person for public queries
Name 89051 0
Christopher Partyka
Address 89051 0
Greater Sydney Area HEMS (NSW Ambulance)
33 Nancy Ellis Leebold Drive
Bankstown Airport NSW 2200
Country 89051 0
Australia
Phone 89051 0
+61 410585798
Fax 89051 0
Email 89051 0
[email protected]
Contact person for scientific queries
Name 89052 0
Christopher Partyka
Address 89052 0
Greater Sydney Area HEMS (NSW Ambulance)
33 Nancy Ellis Leebold Drive
Bankstown Airport NSW 2200
Country 89052 0
Australia
Phone 89052 0
+61 410585798
Fax 89052 0
Email 89052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Prehospital ultrasound results (including component of eFAST scan)
Prehospital physiology & interventions
In hospital 'confirmatory' results (including CT & operative findings).
When will data be available (start and end dates)?
from now (9/03/2020).
No end date determined.
Available to whom?
Clinicians with interest in prehospital ultrasound research & appropriate ethically approved enquiry.
Available for what types of analyses?
As above, data accuracy & confirmation of results.
How or where can data be obtained?
By direct correspondence with the Principle Investigator (Detailed are listed on ANZCTR or direct email to [email protected] ).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
588Study protocol    376498-(Uploaded-01-12-2018-14-23-01)-Study-related document.pdf
589Ethical approval    376498-(Uploaded-01-12-2018-14-23-27)-Study-related document.pdf



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.