Does the novel “Vacuderm“ tourniquet improve cannulation success?
Research type
Research Study
Full title
A randomised controlled trial to assess whether using the novel tourniquet “Vacuderm“ improves cannulation success rate compared to the use of the conventional standard tourniquet?
IRAS ID
201085
Contact name
Kara Baron
Contact email
Sponsor organisation
Olberon Ltd.
Clinicaltrials.gov Identifier
30286, NIHR CPMS; 5525, NIHR: HAEM
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
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 approximately 80% of patients admitted into hospital. It allows for the administration of fluids, drugs, blood or blood products. Cannulation is the most commonly performed invasive medical procedure in hospitalised patients and is frequently life-saving. It is a very common procedure and the NHS in England and Wales currently use approximately 30 million cannulae per year. However, the procedure is not universally successful and the failure rate can range from 15 to 30%. In patients who have had multiple previous cannulations the failure rate can be much higher particularly, for example, in those who have received chemotherapy. Each attempt is painful and causes bruising, with the obvious added distress to the patient. \n\nThe Vacuderm tourniquet is a CE marked class 1 device, specifically designed to assist with difficult cannulation and blood-taking procedures, through the use of a dome feature, which is “pumped“ and further fills the veins making them larger and therefore theoretically easier to access. The aim of this study is to investigate whether the use of the “Vacuderm“ can reduce this failure rate.\n\nThis randomised controlled trial aims to enrol participants from the emergency department, who have had a failed first attempt at cannulation on the current occasion. Patients who have given informed consent will be randomised to either the Vacuderm tourniquet or the conventional standard tourniquet for their second attempt at cannulation. \n\nThe study will last approximately 4 months, to allow sufficient time to enrol sufficient numbers of patients into the study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0898
Date of REC Opinion
16 Dec 2016
REC opinion
Favourable Opinion