pVAD 40 trial
Research type
Research Study
Full title
Can supplementary stabilisation with non-sterile, conformable retention tape and short extension set improve the longevity of peripheral venous access devices? A pilot study for a single blind randomized controlled trial on adult medical patients in need of continuous or intermittent intravenous therapy at a District General Hospital.
IRAS ID
147040
Contact name
Peter O'Donnell
Contact email
Sponsor organisation
University of Bradford
Research summary
This trial aims to assess the advantages and disadvantages of two different ways of securing peripheral venous access devices (also known as “drips”, “cannulae” or “needles”) to the patients’ arm. The purpose of the pilot study is to test the design and methods of the trial on a small number of participants in order to assess the trial’s feasibility. Over a six week period, adult medical in-patients who need intravenous therapy for at least three days are recruited on the acute medical unit at Airedale General Hospital. They are randomly (by chance) assigned to two groups: in one, the devices are secured using current standard care (control group). In the other, they receive additional stabilisation using Hypafix™, a non-sterile conformable retention tape and Smartsite, a short extension set (intervention group). Measurements are taken when the drips are removed; these include how long they were in, if they have fallen out and if they have become inflamed or infected. In the pilot, the collected data are scrutinized to ascertain if the elements of the trial are practical and likely to provide useful information when applied to a larger sample of participants. In the pilot, descriptive statistical analysis is used to detect trends and to aide calculation of the necessary sample size for the actual trial. Due to the small sample size, it will not be possible to generalize the findings. It is the aim of the pilot study to ascertain if a larger study is practicable and gauge if a larger study is likely to answer the research question. Ultimately, the goal is to inform local policy according to the findings of the trial.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0059
Date of REC Opinion
19 Mar 2014
REC opinion
Further Information Favourable Opinion