The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12612000349842
Ethics application status
Approved
Date submitted
23/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Oscar 2 blood pressure measuring device validation during aero-medical transportation of critically ill patients
Scientific title
In critically ill aeromedical patients the accuracy and reliability of the Oscar 2 non-invasive blood pressure is equivalent to invasive blood pressure monitoring techniques
Secondary ID [1] 280205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The accuracy and reliability of non-invasive blood pressure monitoring in critically ill patients during aeromedical transport (fixed wing or helicopter) 286145 0
Condition category
Condition code
Other 286339 286339 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Oscar 2 is an automated device that has been shown to reliably and accurately measure mean pressures in the critically ill patient population. The performance of this device will be examined during aero-medical transportation of 15 patients.
Intervention code [1] 284535 0
Not applicable
Comparator / control treatment
Numeric integrated intra-arterial mean pressures recorded on the patient monitor have been shown to be interchangeable with high fidelity intra-arterial mean pressures, and as such, will be used as the reference standard against which to test Oscar 2 accuracy.
Control group
Active

Outcomes
Primary outcome [1] 286805 0
The agreement between invasive (reference) and non-invasive (test device) pressures. Numeric integrated intra-arterial mean pressures recorded on the patient monitor have been shown to be interchangeable with high fidelity intra-arterial mean pressures and will be used as the reference standard against which to test Oscar 2 accuracy.
Timepoint [1] 286805 0
A total of ten paired pressure measurements, invasive (reference) and non-invasive (test device), for each patient during aeromedical transportation
Secondary outcome [1] 296700 0
Nil
Timepoint [1] 296700 0
Nil

Eligibility
Key inclusion criteria
Patients will be recruited into the study if they are undergoing either fixed-wing or helicopter transportation and:
are adults (> 18 years of age)
already have an intra-arterial catheter inserted into either the radial, ulna or brachial artery
are physiologically stable.
Patients are to be recruited at the discretion of the attending Aeromedical and Medical Retrieval Service (AMRS) physician.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they;
do not fulfil the inclusion criteria
have uni- or bilateral arm or hand trauma
have cardiac arrhythmias such as;
atrial fibrillation, atrial flutter,
a heart rate of less than 40 beats per minute
a heart rate of greater than 200 beats per minute.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)

Funding & Sponsors
Funding source category [1] 284956 0
Other
Name [1] 284956 0
Ambulance Service of NSW
Address [1] 284956 0
Locked Bag 105
Rozelle NSW 2039
Country [1] 284956 0
Australia
Primary sponsor type
Other
Name
Ambulance Service of NSW
Address
Locked Bag 105
Rozelle NSW 2039
Country
Australia
Secondary sponsor category [1] 283827 0
None
Name [1] 283827 0
Address [1] 283827 0
Country [1] 283827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286966 0
Sydney LHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 286966 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 286966 0
Australia
Date submitted for ethics approval [1] 286966 0
19/04/2011
Approval date [1] 286966 0
17/06/2011
Ethics approval number [1] 286966 0
X11-0125

Summary
Brief summary
This study aims to assess the accuracy and reliability of the Oscar 2 non-invasive blood pressure measuring device during;
1. fixed wing; and
2. helicopter
transportation of critically ill patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33970 0
Address 33970 0
Country 33970 0
Phone 33970 0
Fax 33970 0
Email 33970 0
Contact person for public queries
Name 17217 0
Dr Sandy Muecke
Address 17217 0
Ambulance Service of NSW
Locked Bag 105
Rozelle NSW 2039
Country 17217 0
Australia
Phone 17217 0
+612 97793865
Fax 17217 0
+612 97793890
Email 17217 0
smuecke@ambulance.nsw.gov.au
Contact person for scientific queries
Name 8145 0
Dr Sandy Muecke
Address 8145 0
Ambulance Service of NSW
Locked Bag 105
Rozelle NSW 2039
Country 8145 0
Australia
Phone 8145 0
+612 97793865
Fax 8145 0
+612 97793890
Email 8145 0
smuecke@ambulance.nsw.gov.au