Condition category
Not Applicable
Date applied
16/11/2016
Date assigned
27/03/2017
Last edited
27/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cannulation is the procedure in which a patient’s skin is punctured with a needle to allow insertion of a temporary plastic tube into a vein. It can be performed by doctors, phlebotomists, trained nurses and trained health care assistants. Venous cannulation is performed on about 80% of patients admitted into hospital in order to administer fluids, drugs, blood or blood products. Cannulation is the most commonly performed invasive medical procedure in hospitalised patients and is frequently life-saving. The NHS in England and Wales currently use about 26 million cannulae per year. However, the procedure is not always successful and the failure rate can range from 15 to 30%. In patients who have had multiple previous cannulations the failure rate can much higher particularly, for example, in those who have received chemotherapy before. Each attempt is painful and can cause bruising, with the obvious added distress to the patient. The Vacuderm tourniquet is a device designed to assist with difficult cannulation and blood-taking procedures through the use of a dome feature which can be used to "pump" blood into the veins, making them larger and therefore easier to access. The aim of this study is to investigate whether the use of Vacuderm can reduce the failure rate of cannulation.

Who can participate?
Emergency department patients aged 18 and over who require venous cannulation and have had a failed first attempt at cannulation on the current occasion

What does the study involve?
Participants are randomly allocated to undergo a second attempt at cannulation using either the Vacuderm tourniquet or the conventional standard tourniquet. The success rate of cannulation, safety, user acceptability and patient satisfaction are assessed in both groups.

What are the possible benefits and risks of participating?
Cannulation failure is often distressing to patients. There is a chance of failure with every cannulation attempt, leading to patient discomfort and other side effects. Vacuderm may benefit the patients by making cannulation easier. The risk of use of the Vacuderm is not considered greater than that of using a standard tourniquet or blood pressure cuff.

Where is the study run from?
Royal Derby Hospital (UK)

When is the study starting and how long is it expected to run for?
January to April 2017

Who is funding the study?
Olberon Ltd (UK)

Who is the main contact?
Kara Baron
kara@olberon.com

Trial website

Contact information

Type

Public

Primary contact

Miss Kara Baron

ORCID ID

Contact details

Olberon Ltd
The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 (0)115 802 2025
kara@olberon.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

olb/vac/001

Study information

Scientific title

Randomised control trial of a novel tourniquet (Vacuderm tourniquet) which aims to aid further filling of veins through a pumping mechanism

Acronym

Study hypothesis

Does the use of the Vacuderm tourniquet significantly improve the success rate of venous cannulation when compared to the use of a conventional tourniquet?

Ethics approval

Not provided at time of registration

Study design

Single-centre randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Diffficult venous access - cannulation procedure

Intervention

Participants are randomised to undergo cannulation using either the Vacuderm tourniquet or the control, which is the conventional standard tourniquet. Participants will be recruited on to the trial if they have already had an attempted cannulation procedure performed on the current occasion and this has failed; the second attempt will be performed after the participant has been randomised.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Success rate of venous cannulation, measured by recording the tourniquet (Vacuderm or control tourniquet) used and whether the cannulation attempt was successful

Secondary outcome measures

1. Safety: an inspection of the tourniquet site will be carried out after 30 minutes and any adverse events will be recorded in the case report form
2. User acceptability, recorded on the case report form, whether cannulation was successful or not
3. Patient/participant satisfaction, measured using a visual analogue scale (VAS)
4. Cannula size, recorded on the case report form for the first failed attempt at cannulation and the cannula size will again be recorded after randomisation for the second attempt
5. Provisional diagnosis, recorded by the trained delegate on the case report form
6. Potassium levels - haemolysis, recorded by the trained delegate on the case report form
All measured at a single timepoint

Overall trial start date

09/01/2017

Overall trial end date

28/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Emergency department patients aged 18 and over
2. Able to provide informed consent
3. Requiring venous cannulation
4. Has had a first attempt failed cannulation within the emergency department during this attendance
5. The patient has an appropriate site for cannulation in the upper limbs in the opinion of the investigator

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. In the opinion of the investigator the patient has a contra-indication to use of tourniquet or blood pressure cuff (for example a low platelet count causing bruising)
2. Critically ill patients who need emergent IV access
3. Small cannula being used on patient – ie 22 gauge (blue) and smaller

Recruitment start date

09/01/2017

Recruitment end date

28/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Olberon Ltd

Sponsor details

The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 (0)115 802 2025
kara@olberon.com

Sponsor type

Industry

Website

www.olberon.com

Funders

Funder type

Industry

Funder name

Olberon Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be made available once statistical analysis has been performed and written up.

IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Dr Graham Johnson (graham.johnson4@nhs.net).

Intention to publish date

01/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes