Collection of Anonymised Blood Pressure Data During High Risk Surgery

Perioperative Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03653624
• Other study ID #: BPA-DEP-001
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2018
• Source: Directed Systems Limited
• Contact: Thomas H Clutton-Brock, FRCP FRCA
• Phone: +44 121 371 ****
• Email: T.H.CLUTTON-BROCK[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years of age

Related Conditions & MeSH terms

• Perioperative Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Directed Systems Limited	University Hospital Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood pressure	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.	Duration of each patient's surgery, up to 6 hours.