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Trial registered on ANZCTR


Registration number
ACTRN12611001124921
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
27/10/2011
Date last updated
8/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-Hospital Assessment of Noninvasive Tissue Oximetry Monitoring
Scientific title
CareFlight Prospective Observational Trial of Noninvasive Cerebral Oximetry in Pre-Hospital Trauma Patients to Assess Long Term Functional Outcomes
Secondary ID [1] 273259 0
Nil
Universal Trial Number (UTN)
U1111-1125-4004
Trial acronym
The PHANTOM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
trauma 279024 0
Condition category
Condition code
Injuries and Accidents 279210 279210 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of cerebral oximetry parameters during pre-hospital care of patients suffering traumatic injury patient management and transport to hospital. The duration of observation will vary depending on the nature of the pre-hospital accident, treatment time and distance for transport to hospital. Historical experience indicates the average time elapsed from the time of arrival of the treating team until the patient is in hospital is approximately 40 minutes.
Intervention code [1] 269600 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279842 0
Association of absolute cerebral oximetry values with Glasgow Outcome Scale score, Glasgow Outcome Scale - Extended score, Disability Rating Scale and Care and Needs Scale/Pediatric Care and Needs Scale
Timepoint [1] 279842 0
Cerebral oximetry values through patient transport vs outcomes measured as above at follow-up at 6 months and 12 months.
Primary outcome [2] 279843 0
Association of episodes of a fall in cerebral oximetry of greater than or equal to 12% with Glasgow Outcome Scale score, Glasgow Outcome Scale - Extended score, Disability Rating Scale and Care and Needs Scale/Pediatric Care and Needs Scale
Timepoint [2] 279843 0
Cerebral oximetry values through pre-hospital care and transport vs outcome measures as above at 6 months and 12 months.
Secondary outcome [1] 294560 0
Association of cerebral oximetry values and mortality
Timepoint [1] 294560 0
Mortality at 24 hours, 30 days and survival to discharge.
Secondary outcome [2] 294561 0
Association of cerebral oximetry values with injuries identified on cerebral imaging
Timepoint [2] 294561 0
Cerebral oximetry values vs initial CT or MRI head findings.
Secondary outcome [3] 294562 0
Association of cerebral oximetry values and length of ICU stay
Timepoint [3] 294562 0
Measured at time of patient discharge.
Secondary outcome [4] 294563 0
Association of end-tidal carbon dioxide and cerebral oximetry values
Timepoint [4] 294563 0
Measured during patient pre-hospital treatment and transport.
Secondary outcome [5] 294564 0
Association of peripheral pulse oximetry values and cerebral oximetry values
Timepoint [5] 294564 0
Recorded during pre-hospital treatment and transport of patients.
Secondary outcome [6] 294565 0
Association of non-invasive blood pressure values and cerebral oximetry values
Timepoint [6] 294565 0
Recorded during pre-hospital treatment and transport of patients.
Secondary outcome [7] 294566 0
Association of first recorded Glasgow Coma Scale scores and cerebral oximetry
Timepoint [7] 294566 0
Recorded during patient transport and pre-hospital treatment

Eligibility
Key inclusion criteria
All patients being transported by a rapid response trauma response team (incorporating a doctor-paramedic team). This may include, but would not be limited to:
Patients with a blunt force mechanism for head injury with initial evidence of reduced level of consciousness.
Patients with major blunt mechanism thoracic and abdominal trauma.
Patients with major haemorrhage.
Patients with penetrating trauma.
Patients with severe burn injuries.
Patients with major extremity injury.
Patients with trauma and major compression injury.
Minimum age
1 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients less than 1 year old or more than 70 years old.
Patients with a history of previous neurological disease or neurological trauma.
Patients with no mechanism for trauma.
Patients with significant haematomas or lacerations in the forehead area.
Patients in whom consent is not obtained at a later time

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power analysis is challenging as pre-existing data sets are not available. Using data under analysis for publication relating to traumatic brain injury, the incidence of mortality vs poor or good outcomes on Glasgow Outcome Score was utilised to calculate numbers of severe brain injury patients required for recruitment at 242, with total numbers required therefore 1210.
For primary outcomes, area under the curve for cerebral oximetry value less than or equal to 45% will be used to allow grouping and ocmparison to EGOS outcome assessment at 6 and 12 months. Time series analysis will also be undertaken.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 3923 0
Switzerland
State/province [1] 3923 0

Funding & Sponsors
Funding source category [1] 284085 0
Charities/Societies/Foundations
Name [1] 284085 0
CareFlight
Address [1] 284085 0
4 Barden St, Northmead, NSW, 2152.
Country [1] 284085 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Weatherall
Address
PHANTOM Study Chief Investigator
CareFlight NSW
4 Barden St
Northmead
NSW 2152
Country
Australia
Secondary sponsor category [1] 269051 0
Individual
Name [1] 269051 0
Dr Alan Garner
Address [1] 269051 0
Medical Director
CareFlight NSW
4 Barden St
Northmead, NSW
2152
Country [1] 269051 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272048 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 272048 0
Ethics committee country [1] 272048 0
Date submitted for ethics approval [1] 272048 0
09/11/2011
Approval date [1] 272048 0
28/05/2013
Ethics approval number [1] 272048 0

Summary
Brief summary
A lot of the things we do when looking after patients with significant injuries after accidents relies on using monitors to provide us with information. When it comes to the brain, we often measures things elsewhere in the body and assume that if those things are normal, we're doing the best we can for the brain, but we can't be sure.

This study is designed to look at a kind of monitor that you can apply to the skin which gives you information directly about oxygen balance in the brain. The hypothesis is that there is an association between the values shown by the monitor in injured patients and how well they recover after their injury - meaning that if the numbers are abnormal, it correlates with worse recovery later.
Trial website
Nil
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 33300 0
Dr Andrew Weatherall
Address 33300 0
c/- CareFlight
4 Barden St
Northmead, NSW, 2152
Australia
Country 33300 0
Australia
Phone 33300 0
+61298435100
Fax 33300 0
Email 33300 0
andrew.weatherall@careflight.org
Contact person for public queries
Name 16547 0
Dr Dr Andrew Weatherall
Address 16547 0
c/- CareFlight
4 Barden St
Northmead NSW 2152
Country 16547 0
Australia
Phone 16547 0
+61298435100
Fax 16547 0
Email 16547 0
andrew.weatherall@careflight.org
Contact person for scientific queries
Name 7475 0
Dr Dr Andrew Weatherall
Address 7475 0
c/- CareFlight
4 Barden St
Northmead NSW 2152
Country 7475 0
Australia
Phone 7475 0
+61298435100
Fax 7475 0
Email 7475 0
andrew.weatherall@careflight.org

No information has been provided regarding IPD availability
Summary results
No Results