Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000957291
Ethics application status
Not yet submitted
Date submitted
14/10/2009
Date registered
6/11/2009
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Arterial Blood Gas Sampling: 23G Versus 25G Needle - A Randomised Control Study to Compare Pain
Scientific title
Arterial Blood Gas Needle Study: A Randomised Control Study Comparing 23 gauge Versus 25 gauge Needle Success & Pain Score
Secondary ID [1] 283836 0
Arterial Blood Gas Sampling: 23G Versus 25G Needle - A Randomised Control Study to Compare Pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in arterial blood gas sampling 252005 0
Complications related to arterial blood gas sampling 290813 0
Condition category
Condition code
Other 252199 252199 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Taking small amount of blood (0.5ml) from the radial artery at the wrist with a thicker 23G needle.
Intervention code [1] 241415 0
Treatment: Devices
Intervention code [2] 241418 0
Treatment: Other
Comparator / control treatment
Taking small amount of blood (0.5ml) from the radial artery at the wrist with a thinner 25G needle.
Control group
Active

Outcomes
Primary outcome [1] 253077 0
The degree of pain experienced by patients during an arterial blood gas puncture with different gauge needles measured on a 10cm visual analogue scale assessed after each puncture.
Timepoint [1] 253077 0
June 2010 to July 2012
Secondary outcome [1] 257923 0
The success rates & complications assessed once during an arterial blood gas puncture with different gauge needles. Procedural difficulty measured on a 10cm visual analogue scale.
Timepoint [1] 257923 0
June 2010 to July 2012

Eligibility
Key inclusion criteria
All patients presenting to the emergency department who need to undergo arterial blood gas analysis as part of their diagnostic work up will be considered candidates for the study provided they do not fulfil the absolute exclusion criteria.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with altered mental/cognitive/medical state either acute or chronic deemed not able to convey pain score accurately.
2. Unwell patients who require urgent medical intervention which precludes informed consent such as Category 1 patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
31/07/2012
Actual
31/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 7664 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 243879 0
Hospital
Name [1] 243879 0
Westmead Hospital
Country [1] 243879 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital Emergency Department
Address
Hawkesbury Road
Westmead NSW 2165
Country
Australia
Secondary sponsor category [1] 251226 0
None
Name [1] 251226 0
Address [1] 251226 0
Country [1] 251226 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243998 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 243998 0
Hawkesbury Road
Westmead NSW 2165
Ethics committee country [1] 243998 0
Australia
Date submitted for ethics approval [1] 243998 0
15/10/2009
Approval date [1] 243998 0
Ethics approval number [1] 243998 0

Summary
Brief summary
The primary purpose ot the study is compare two of the commonly used needles in arterial blood gas taking and to determine the level of pain/success rate & complications. Whilst the smaller needle may be theoritically less painful, there is uncertainty whether it is more difficult to perform leading to lower success rates & complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30390 0
Dr Kenny Yee
Address 30390 0
Westmead Hospital
Hawkesbury Road
Westmead 2145 NSW
Country 30390 0
Australia
Phone 30390 0
(+612) 98455555
Fax 30390 0
Email 30390 0
[email protected]
Contact person for public queries
Name 13637 0
Dr Kenny Yee
Address 13637 0
Hawkesbury Road
Westmead NSW 2165
Country 13637 0
Australia
Phone 13637 0
+61298455555
Fax 13637 0
Email 13637 0
[email protected]
Contact person for scientific queries
Name 4565 0
Dr Kenny Yee
Address 4565 0
Hawkesbury Road
Westmead NSW 2165
Country 4565 0
Australia
Phone 4565 0
+61298455555
Fax 4565 0
Email 4565 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
SourceTitleYear of PublicationDOI
EmbaseABG needle study: A randomised control study comparing 23G versus 25G needle success and pain scores.2015https://dx.doi.org/10.1136/emermed-2014-203600
N.B. These documents automatically identified may not have been verified by the study sponsor.