Perioperative Hypertension Clinical Trial
Official title:
Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
This is a single centre, prospective, non-randomised clinical investigation to be undertaken
at the Queen Elizabeth Hospital, Edgbaston, Birmingham.
The clinical investigation will collect fully anonymised perioperative blood pressure data
from patients undergoing elective high risk surgery.
The Sponsor of this clinical investigation, Directed Systems Limited, is developing a new
medical device, BP Assist, which provides guidance to anaesthetists in relation to the
real-time management of patient cardiovascular physiology.
This clinical investigation is designed to collect fully anonymised perioperative blood
pressure data from patients undergoing high risk surgical procedures.
It is increasingly being recognised that in high risk surgery, the perioperative incidence
and duration of hypotensive episodes (MAP <60mmHg) can adversely impact postoperative
outcome.
Collecting continuous perioperative blood pressure data will enable hypotensive episodes to
be recorded. Such data will be used to aid the development and testing of algorithms involved
in generating the guidance provided by BP Assist.
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