Collection of Anonymised Blood Pressure Data During High Risk Surgery

• Conditions: Perioperative Hypertension

• Registration Number: NCT03653624
• Lead Sponsor: Directed Systems Limited

Brief 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.

Detailed 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 Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19
• Study Start: 2019-10-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Male or female, 18 years of age or older; undergoiing elective high risk surgery

Exclusion Criteria

• <18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative blood pressure	Duration of each patient's surgery, up to 6 hours.	The primary objective of this clinical investigation is to collect fully anonymised, continuous, perioperative blood pressure data from ten patients undergoing elective high-risk surgery. Systolic and mean arterial pressures will be recorded.