iSTABILISE
Research type
Research Study
Full title
A feasibility study to investigate whether continuous non-invasive monitoring improve stability of intraoperative blood pressure (iSTABILISE)
IRAS ID
261698
Contact name
William Rook
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 4 days
Research summary
Low blood pressure during surgery has been found to lead to a higher risk of kidney or heart damage, and higher risk of death after surgery. This study is a small scale ('pilot') study in a small number of sites to determine whether it is feasible to run the same trial on a larger scale. The overall study, which this is a small scale version of, is testing whether a different way of monitoring blood pressure during surgery prevents dangerously low blood pressure occurring as frequently in patients having a broken hip repaired.
Normally, blood pressure is monitored with a cuff around the upper arm which inflates and deflates every few minutes; so called 'intermittent' monitoring. It gives a reading every 3-5 minutes. We want to compare this with a monitor which uses two extra small cuffs around the fingers to give a constant, so called 'continuous' measurement of blood pressure. We think that knowing about blood pressure sooner may lead to the anaesthetist treating low blood pressure more quickly, and this may reduce some of the harms associated with low blood pressure, such as heart or kidney damage, or an increase in the overall risk of death after these operations.
This study is a feasibility study, meaning that we are testing whether the way we would like to run the clinical trial works, and to find out if alterations need to be made. Therefore, the main aim, or outcome of the study is the proportion of all the patients who could be entered into the clinical trial that actually are. Other aims, or outcomes, are to measure the same variables that we would measure if we carry out the large scale trial, so we can make estimates of how big the large scale trial would need to be.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0164
Date of REC Opinion
6 Jun 2019
REC opinion
Favourable Opinion