Collection of Anonymised Blood Pressure Data During High Risk Surgery
Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
1 other identifier
observational
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJuly 19, 2019
August 1, 2018
5 months
August 23, 2018
July 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Interventions
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
Patients undergoing elective high risk surgery at Queen Elizabeth Hospital, Birmingham, UK.
You may qualify if:
- Male or female, 18 years of age or older; undergoiing elective high risk surgery
You may not qualify if:
- \<18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Directed Systems Limitedlead
- University Hospital Birminghamcollaborator
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2018
First Posted
August 31, 2018
Study Start
October 1, 2019
Primary Completion
March 1, 2020
Study Completion
April 1, 2020
Last Updated
July 19, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share