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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03653624
Study type Observational
Source Directed Systems Limited
Contact Thomas H Clutton-Brock, FRCP FRCA
Phone +44 121 371 ****
Email T.H.CLUTTON-BROCK@bham.ac.uk
Status Not yet recruiting
Phase
Start date October 1, 2019
Completion date April 1, 2020

See also
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Withdrawn NCT03678207 - The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Active, not recruiting NCT03019146 - Exploring Time-efficient Strategies to Improve Fitness for Surgery in Older Adults N/A