Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000463370
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
30/03/2017
Date last updated
7/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does drinking water and applying heat increase vein size?
Scientific title
The effect of hydration and heat on upper extremity vein diameter and distance of vein from skin surface in healthy volunteers.
Secondary ID [1] 291103 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients requiring intravenous treatments 301925 0
patients requiring venepuncture 301927 0
Condition category
Condition code
Cardiovascular 301581 301581 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three arm parallel randomised controlled trial will be undertaken to determine the effect of hydration and heat on vein diameter and distance of vein from skin surface. 39 participants (13 each group) will be recruited from staff and students of the University of South Australia. Participants will be invited to register their interest by emailing the researchers. Once registered, participants will be emailed an information sheet and consent form. The participants will be asked to email a signed consent form to the researchers prior to study commencement. Registration details will be entered into a spreadsheet and used to randomise participants to one of three groups control, heat or hydration. This will be an unblinded RCT due to the nature of the interventions.
All participants will be asked to fast (food and fluid) from 2400 the previous night to when the measurements occur. The researchers will undertake baseline measurement vein measurements using a portable ultrasound early the next day. Two veins on the left arm commonly used for venepuncture and PIVC insertion will be identified using ultrasound. A mark will be applied to the measurement site with nonpermanent pen. Both the diameter and depth of these veins will be determined using the inbuilt callipers of a portable SonoSite SSeries ultrasound machine. Participants will be given a short questionnaire to determine age, BMI, gender, medical history (diagnosed by medical practitioner) tobacco and medication use. Additionally, level of physical activity will be measured (Godin LeisureTime Exercise Questionnaire).
Participants allocated to the fluid arm will be given 1 litre of room bottled water temperature (approx. 22 degrees Celsius) and asked to consume this over 30 minutes. Those in the arm receiving heat intervention will have a wheat bag (warmed in a domestic microwave on high power for 2 minutes) applied directly over the veins of interest in the cubital fossa/forearm area for 15 minutes. Participants in the heat arm will have the second vein measurement after 15 minutes of heat application. The fluid and control group will have the second measurements undertaken 1 hour after the baseline measurements.
Intervention code [1] 297095 0
Treatment: Other
Intervention code [2] 297132 0
Treatment: Devices
Comparator / control treatment
Participants in the control arm will not receive fluid or heat and will be asked to sit quietly until the second vein diameter and depth measurements (1 hour after baseline measurement).
Control group
Active

Outcomes
Primary outcome [1] 300989 0
A portable SonoSite S-Series ultrasound machine (SonoSite, Bothell, WA) with a 13-6 MHz linear probe and vascular pre-set will be used to identify and measure vein diameter
Two veins (median cubital and cephalic vein) on the left arm of participants will be measured. The median cubital vein will be measured at the cubital fossa. The cephalic vein measured at the most distal point that the vein is identified on the forearm in a pre-determined section (between 30mm distal from the antecubital fossa and 120mm proximal to the radial styloid). The distance from these anatomical landmarks will be measured and recorded. A mark will be made at both sites with non-permanent ink. The transducer will be manoeuvred along the mark and angled from left to right to obtain the clearest image of the vein and reduce artefacts in the image. Light transducer pressure will be used to avoid vein compression and gain/depth will be optimized for each image. The inbuilt callipers of the ultrasound will be used to measure the anterior posterior diameter of the vein
Timepoint [1] 300989 0
Participants in the heat arm will have the second vein measurement after 15 minutes of heat application. The fluid and control groups will have the second measurements undertaken 1 hour after the baseline measurements.
Secondary outcome [1] 333306 0
A portable SonoSite S-Series ultrasound machine (SonoSite, Bothell, WA) with a 13-6 MHz linear probe and vascular pre-set will be used to measure the distance of the vein from the skin surface.
Two veins (median cubital and cephalic vein) on the left arm of participants will be measured. The median cubital vein will be measured at the cubital fossa. The cephalic vein measured at the most distal point that the vein is identified on the forearm in a pre-determined section (between 30mm distal from the antecubital fossa and 120mm proximal to the radial styloid). The distance from these anatomical landmarks will be measured and recorded. A mark will be made at both sites with non-permanent ink. The transducer will be manoeuvred along the mark and angled from left to right to obtain the clearest image of the vein and reduce artefacts in the image. Light transducer pressure will be used to avoid vein compression and gain/depth will be optimized for each image. The inbuilt callipers of the ultrasound will be used to measure the distance between the uppermost vein wall and skin surface.
Timepoint [1] 333306 0
Participants in the heat arm will have the second measurement after 15 minutes of heat application. The fluid and control groups will have the second measurements undertaken 1 hour after the baseline measurements.

Eligibility
Key inclusion criteria
Staff and students at the University of South Australia City East campus will be invited to take part.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women, insulin dependent diabetics and participants who have any other serious health conditions that may be effected by fasting will be excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There was a paucity of data to inform this power analysis. We have used the effect demonstrated in Zhu et al. (2015) to guide our calculation. They demonstrated a 2mm increase in subclavian vein diameter after rehydration with one litre of intravenous fluid. It was expected that there would be an increase in vein diameter of 2mm after intervention and no change in the control group (SD 1.5mm). A two group t- test found that this would require 13 per group to achieve 80% power with a 0.025 significance level. Descriptive statistics will be used to present participant variables such as age, gender and activity levels. Differences in mean vein diameter and distance of vein from skin surface will be analysed using paired t-tests to determine the effect of localized heat and oral hydration on vein diameter and depth.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/12/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
31/03/2017
Date of last data collection
Anticipated
4/04/2017
Actual
31/03/2017
Sample size
Target
39
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15254 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 295542 0
University
Name [1] 295542 0
University of South Australia
Country [1] 295542 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Sharp
Address
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 294360 0
Individual
Name [1] 294360 0
Dr Jessie Childs
Address [1] 294360 0
School of Health Sciences
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country [1] 294360 0
Australia
Secondary sponsor category [2] 294362 0
Individual
Name [2] 294362 0
Professor Adrian Esterman
Address [2] 294362 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country [2] 294362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296863 0
University of South Australia
Ethics committee address [1] 296863 0
Ethics committee country [1] 296863 0
Australia
Date submitted for ethics approval [1] 296863 0
10/10/2016
Approval date [1] 296863 0
14/10/2016
Ethics approval number [1] 296863 0
0000035866

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72266 0
Dr Rebecca Sharp
Address 72266 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country 72266 0
Australia
Phone 72266 0
+61 8 8302 2663
Fax 72266 0
Email 72266 0
[email protected]
Contact person for public queries
Name 72267 0
Rebecca Sharp
Address 72267 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country 72267 0
Australia
Phone 72267 0
+61 8 8302 2663
Fax 72267 0
Email 72267 0
[email protected]
Contact person for scientific queries
Name 72268 0
Rebecca Sharp
Address 72268 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country 72268 0
Australia
Phone 72268 0
+61 8 8302 2663
Fax 72268 0
Email 72268 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.