Perioperative Hypertension
Conditions
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.
Interventions
OTHERNo 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.
Sponsors
University Hospital Birmingham
Directed Systems Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male or female, 18 years of age or older; undergoiing elective high risk surgery
Exclusion criteria
* \<18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactThomas H Clutton-Brock, FRCP FRCA
Outcome results
None listed