Perioperative HypertensionNCT03653624
Collection of Anonymised Blood Pressure Data During High Risk Surgery
An observational study of Perioperative Hypertension, run by Directed Systems Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hypertension
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing elective high risk surgery at Queen Elizabeth Hospital, Birmingham, UK.
Who may be able to join
- Male or female, 18 years of age or older; undergoiing elective high risk surgery
Who cannot join
- <18 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
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.
Read the 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.
- Conditions
- Perioperative Hypertension
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is involved int his study. Fully anonymised blood pressure data will be collected from the vital signs monitors in the operating room.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of each patient's surgery, up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Oct 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Directed Systems Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653624
- Sponsor's protocol ID
- BPA-DEP-001
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery
- ClinicalTrials.gov ID
- NCT03653624
- Acronym / sponsor ID
- BPA-DEP-001
- Conditions
- Perioperative Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Directed Systems LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective high risk surgery at Queen Elizabeth Hospital, Birmingham, UK.
Key inclusion criteria (1 listed)
- Male or female, 18 years of age or older; undergoiing elective high risk surgery
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention is involved int his study. Fully anonymised blood pressure data will be collected from the vital signs monitors in the operating room. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Perioperative Hypertension
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Not yet recruitingObservational study
Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery
Lumbar Spinal Stenosis, Lumbar Degenerative Disease
Enrolling by invitation
Comparison of Post-Craniotomy Blood Pressure Targets
Intracranial Hemorrhage, Hypertensive, Craniotomy Tumor Removal Surgery
Not yet recruitingPhase 2
PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Hypertension, run by Directed Systems Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas H Clutton-Brock, FRCP FRCA (+44 121 371 ****, T.H.CLUTTON-BROCK@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood pressure (time frame: Duration of each patient's surgery, up to 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.