HDA-USE
Research type
Research Study
Full title
Hypotension Decision Assist – Use, Safety and Efficacy
IRAS ID
292141
Contact name
Thomas Clutton-Brock
Contact email
Sponsor organisation
Directed Systems Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
Surgery under general anaesthetic is very common but has some risks for patients and anaesthetists are always looking for ways to make surgery safer. One risk is from a drop in blood pressure, known as Intraoperative Hypotension (IOH). IOH happens in about 1 in 4 surgeries and can cause complications after the operation that can mean the patient takes longer to recover in hospital. The surgical team uses machines to measure blood pressure and other vital signs during surgery, and Directed Systems Ltd has made a new kind of monitor to make the anaesthetist’s job easier.
The system called Hypotension Decision Assist (HDA) will work with the current vital signs monitors to show the anaesthetist more information about the patient. This will include information on blood pressure and heart function and how these change over time, and will also show the anaesthetist if blood pressure is dropping before it reaches a dangerous level.
The system has been carefully tested in the laboratory and by anaesthetists in a mock up. The system now needs to be tested during real operations to make sure it gives the anaesthetist useful information at the right time during surgery.
This study will recruit 30 patients who need to have an operation where an arterial line is likely to be used. Suitable patients will be contacted to ask if they would like to take part and will be sent an information sheet explaining what the study will involve. There will be no change to the treatment the patient gets before, during or after the operation in this study, and they would not be aware of the use of the HDA system. Results from this study will help to design a later clinical study where changes in treatment will be looked at.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0129
Date of REC Opinion
25 May 2021
REC opinion
Favourable Opinion