Collection of Anonymised Blood Pressure Data During High Risk Surgery

NCT ID: NCT03653624

Last Updated: 2019-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-04-01

Brief Summary

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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

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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

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Perioperative Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham

OTHER

Sponsor Role collaborator

Directed Systems Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Thomas H Clutton-Brock, FRCP FRCA

Role: CONTACT

+44 121 371 ****

Other Identifiers

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BPA-DEP-001

Identifier Type: -

Identifier Source: org_study_id

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