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Collection of Anonymised Blood Pressure Data During High Risk Surgery

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ClinicalTrials.gov Identifier: NCT03653624
Recruitment Status : Unknown
Verified August 2018 by Directed Systems Limited.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
University Hospital Birmingham
Information provided by (Responsible Party):
Directed Systems Limited

Study Description
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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.


Condition or disease Intervention/treatment
Perioperative Hypertension Other: No intervention

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Perioperative blood pressure [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective high risk surgery at Queen Elizabeth Hospital, Birmingham, UK.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <18 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653624


Contacts
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Contact: Thomas H Clutton-Brock, FRCP FRCA +44 121 371 **** T.H.CLUTTON-BROCK@bham.ac.uk

Sponsors and Collaborators
Directed Systems Limited
University Hospital Birmingham
More Information
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Responsible Party: Directed Systems Limited
ClinicalTrials.gov Identifier: NCT03653624    
Other Study ID Numbers: BPA-DEP-001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases