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

ISRCTN ISRCTN52096917
DOI https://doi.org/10.1186/ISRCTN52096917
Secondary identifying numbers olb/vac/001
Submission date
16/11/2016
Registration date
27/03/2017
Last edited
07/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Kara Baron
Public

Olberon Ltd
The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Phone +44 (0)115 802 2025
Email kara@olberon.com

Study information

Study designSingle-centre randomised control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleRandomised control trial of a novel tourniquet (Vacuderm tourniquet) which aims to aid further filling of veins through a pumping mechanism
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDiffficult venous access - cannulation procedure
InterventionParticipants 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureSuccess rate of venous cannulation, measured by recording the tourniquet (Vacuderm or control tourniquet) used and whether the cannulation attempt was successful
Secondary outcome measures1. 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 study start date09/01/2017
Completion date28/04/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment09/01/2017
Date of final enrolment28/04/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor information

Olberon Ltd
Industry

The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Phone +44 (0)115 802 2025
Email kara@olberon.com
Website www.olberon.com
ROR logo "ROR" https://ror.org/01rjdjc72

Funders

Funder type

Industry

Olberon Ltd

No information available

Results and Publications

Intention to publish date01/07/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults will be made available once statistical analysis has been performed and written up.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Dr Graham Johnson (graham.johnson4@nhs.net).

Editorial Notes

07/05/2021: Proactive update review. No publications found.