Collection of Anonymised Blood Pressure Data During High Risk Surgery
NCT ID: NCT03653624
Last Updated: 2019-07-19
Study Results
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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UNKNOWN
10 participants
OBSERVATIONAL
2019-10-01
2020-04-01
Brief Summary
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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.
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Detailed Description
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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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Study Design
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CASE_ONLY
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital Birmingham
OTHER
Directed Systems Limited
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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BPA-DEP-001
Identifier Type: -
Identifier Source: org_study_id
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