Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000977077
Ethics application status
Approved
Date submitted
11/11/2010
Date registered
12/11/2010
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the left upper arm and forearm non-invasive blood pressure's in adult Emergency Department patients: a randomised cross over study
Scientific title
Comparison of the left upper arm and forearm non-invasive blood pressures in adult Emergency Department patients: a randomised cross over trial
Secondary ID [1] 253068 0
N/A
Universal Trial Number (UTN)
U1111-1117-4382
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agreement between left upper and lower arm blood pressure measurement 258633 0
Condition category
Condition code
Cardiovascular 258774 258774 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will have both their left upper and lower arm blood pressure measured sequentially (within 3 minutes) using an automated non-invasive blood pressure device.

A cross-over methodology will be utilised. The order of blood pressure measurement will be randomised.
The left lower arm blood pressure will be the intervention arm.
Intervention code [1] 257589 0
Early detection / Screening
Comparator / control treatment
A single left upper arm non-invasive blood pressure (NIBP) measurement
Control group
Active

Outcomes
Primary outcome [1] 259638 0
To assess agreement between the mean difference of the systolic blood pressures as measured on the left upper arm and forearm using Bland Altman plots.
Timepoint [1] 259638 0
On presentation to the Emergency Department
Secondary outcome [1] 266298 0
None
Timepoint [1] 266298 0
N/A

Eligibility
Key inclusion criteria
- Adult presenting to Emergency Department.
- Age 18years or older.
- The patient can provide consent,
- The patient is able to have a blood pressure takin on their left upper arm and forearm.
- The patient is able to sit at a 45 degree angle on a stretcher.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Australasian Triage Code 1 patient's

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study sample will be obtained sequentially from the Emergency Department current in-patient list.

Allocation concealment will be done by sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation using computer generated numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 3033 0
New Zealand
State/province [1] 3033 0

Funding & Sponsors
Funding source category [1] 258038 0
Self funded/Unfunded
Name [1] 258038 0
Karen Schimanski
Country [1] 258038 0
New Zealand
Primary sponsor type
Individual
Name
Karen Schimanski
Address
Nurse Consultant
Adult Emergency Department
c/- Auckland District Health Board
2 Park Rd
Grafton
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257228 0
None
Name [1] 257228 0
Address [1] 257228 0
Country [1] 257228 0
Other collaborator category [1] 251649 0
University
Name [1] 251649 0
Dr Andrew Jull
Address [1] 251649 0
Associate Professor
School of Nursing
Senior Research Fellow
Clinical Trials Research Unit
Universiity of Auckland
Nurse Advisor - Quality

c/- School of Nursing
University of Auckland
Private Bag 92019
Auckland
New Zealand
Country [1] 251649 0
New Zealand
Other collaborator category [2] 251650 0
Individual
Name [2] 251650 0
Nancy Mitchell
Address [2] 251650 0
Nurse Educator
Adult Emergency Department
c/- Auckland District Health Board
2 Park Rd
Grafton
Auckland 1010
New Zealand
Country [2] 251650 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260035 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 260035 0
Ministry of Health
3rd Floor, BNZ building
354 Victoria St,
PO box 1031
Hamilton, 3204
New Zealanc
Ethics committee country [1] 260035 0
New Zealand
Date submitted for ethics approval [1] 260035 0
30/11/2010
Approval date [1] 260035 0
Ethics approval number [1] 260035 0

Summary
Brief summary
It is important Emergency Department (ED) staff gain accurate and timely blood pressure measures on acute patients. The blood pressure (BP) measurement is a vital component of a patient’s assessment. It provides an essential cardiovascular measurement for ED clinician’s to use for assessing the stability of a patient and for prescribing acute medical treatment.

Evidence advocates that auscultation of the upper arm at heart level is the recommended technique for a non-invasive blood pressure measurement. However internationally, when the upper arm is unavailable or the patients arm circumference is too large; the forearm is being utilised as a blood pressure site. Although guidelines suggest that the forearm can be used, there is limited evidence to support this practice. In New Zealand, a forearm BP is not common practice.

Forty four Emergency Department patients that meet the inclusion criteria will be recruited to have both their left upper and lower arm blood pressure measures taken using standard technique by an automated device. The order of blood pressure measurement will be randomised using a simple block two computer generated sequence. Allocation concealment will be done by sequentially numbered sealed opaque envelopes. Agreement between the two measures will be determined using Bland-Altman plots which plot the difference between the two blood pressure measures (for both systolic and diastolic blood pressure) against the average of the two measures
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31901 0
Address 31901 0
Country 31901 0
Phone 31901 0
Fax 31901 0
Email 31901 0
Contact person for public queries
Name 15148 0
Karen Schimanski
Address 15148 0
Nurse Consultant
Adult Emergency Department
c/- Auckland District Health Board
2 Park Rd
Grafton
Auckland 1010
New Zealand
Country 15148 0
New Zealand
Phone 15148 0
++ 64 9 307 4949 ext 24226
Fax 15148 0
Email 15148 0
[email protected]
Contact person for scientific queries
Name 6076 0
Karen Schimanski
Address 6076 0
Nurse Consultant
Adult Emergency Department
c/- Auckland District Health Board
2 Park Rd
Grafton
Auckland 1010
New Zealand
Country 6076 0
New Zealand
Phone 6076 0
++ 64 9 307 4949 ext 24226
Fax 6076 0
Email 6076 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
No additional documents have been identified.