ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Cerebral oximetry values through patient transport vs outcomes measured as above at follow-up at 6 months and 12 months.

Primary outcome [2]

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]

Cerebral oximetry values through pre-hospital care and transport vs outcome measures as above at 6 months and 12 months.

Secondary outcome [1]

Association of cerebral oximetry values and mortality

Timepoint [1]

Mortality at 24 hours, 30 days and survival to discharge.

Secondary outcome [2]

Association of cerebral oximetry values with injuries identified on cerebral imaging

Timepoint [2]

Cerebral oximetry values vs initial CT or MRI head findings.

Secondary outcome [3]

Association of cerebral oximetry values and length of ICU stay

Timepoint [3]

Measured at time of patient discharge.

Secondary outcome [4]

Association of end-tidal carbon dioxide and cerebral oximetry values

Timepoint [4]

Measured during patient pre-hospital treatment and transport.

Secondary outcome [5]

Association of peripheral pulse oximetry values and cerebral oximetry values

Timepoint [5]

Recorded during pre-hospital treatment and transport of patients.

Secondary outcome [6]

Association of non-invasive blood pressure values and cerebral oximetry values

Timepoint [6]

Recorded during pre-hospital treatment and transport of patients.

Secondary outcome [7]

Association of first recorded Glasgow Coma Scale scores and cerebral oximetry

Timepoint [7]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2014

Actual

6/07/2014

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1210

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment outside Australia

Country [1]

Switzerland

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

CareFlight

Address [1]

4 Barden St, Northmead, NSW, 2152.

Country [1]

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]

Individual

Name [1]

Dr Alan Garner

Address [1]

Medical Director
CareFlight NSW
4 Barden St
Northmead, NSW
2152

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospital Network Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

09/11/2011

Approval date [1]

28/05/2013

Ethics approval number [1]

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

Dr Andrew Weatherall

Address

c/- CareFlight
4 Barden St
Northmead, NSW, 2152
Australia

Country

Australia

Phone

+61298435100

Fax

andrew.weatherall@careflight.org

Contact person for public queries

Name

Dr Andrew Weatherall

Address

c/- CareFlight
4 Barden St
Northmead NSW 2152

Country

Australia

Phone

+61298435100

Fax

andrew.weatherall@careflight.org

Contact person for scientific queries

Name

Dr Andrew Weatherall

Address

c/- CareFlight
4 Barden St
Northmead NSW 2152

Country

Australia

Phone

+61298435100

Fax

andrew.weatherall@careflight.org

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

Source	Title	Year of Publication	DOI
Embase	Study protocol for the PHANTOM study: prehospital assessment of noninvasive tissue oximetry monitoring.	2014	https://dx.doi.org/10.1186/s13049-014-0057-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically