NCT03653624

Collection of Anonymised Blood Pressure Data During High Risk Surgery

Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Directed Systems Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Perioperative Hypertension

Interventions

Type	Name	Description
OTHER	No intervention	No intervention is involved int his study. Fully anonymised blood pressure data will be collected from the vital signs monitors in the operating room.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-03-01
• Completion: 2020-04-01
• First posted: 2018-08-31
• Last updated: 2019-07-19