NCT05101590

Brief Summary

This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

October 1, 2021

Last Update Submit

March 21, 2022

Conditions

Intraoperative Hypotension

Keywords

HypotensionIntraoperative careIntraoperative complications

Outcome Measures

Primary Outcomes (8)

  • Display of trends in mean arterial pressure measured in millimetres of mercury (mmHg)

    Operative time were HDA derives and displays mean arterial pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends in systolic blood pressure measured in millimetres of mercury (mmHg)

    Operative time were HDA derives and displays systolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends in diastolic blood pressure measured in millimetres of mercury (mmHg)

    Operative time were HDA derives and displays diastolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends in heart rate measured in beats per minute (bpm)

    Operative time were HDA derives and displays heart rate (bpm) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends of changes in heart rate (percentage) over the previous five minutes measured as a percentage

    Operative time were HDA derives and displays changes in heart rate (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends of changes in cardiac output (percentage) over the previous five minutes measured as a percentage

    Operative time were HDA derives and displays changes in cardiac output (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Display of trends of changes in systemic vascular resistance (percentage) over the previous five minutes measured as a percentage

    Operative time were HDA derives and displays changes in systemic vascular resistance (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.

    Intraoperative

  • Adverse events (AEs) related to blood pressure attributable to HDA

    Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of HDA

    Intraoperative

Secondary Outcomes (4)

  • Measurement of intraoperative hypotension

    Intraoperative

  • Number and type of intervention made by anaesthetists

    Intraoperative

  • Comparison of HDA projected trend feature

    Intraoperative

  • Anaesthetists evaluation of use against a five point Likert-type scale

    Intraoperative

Study Arms (1)

Monitored with HDA

EXPERIMENTAL

Participants undergoing elective major surgery and have an arterial line as part of their standard care with HDA included as part of their care

Device: Monitored by HDA

Interventions

Monitored by HDADEVICE

Participants undergoing elective major surgery with an arterial line as part of their standard care and additional monitoring with HDA as part of their care.

Monitored with HDA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years) due to undergo elective surgery who are likely to have an arterial line sited as part of their standard intraoperative care.
  • Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
  • Ability and willingness to provide informed consent
  • Expected duration of anaesthesia \> 60 minutes
  • Intra-arterial monitoring is part of routine clinical care

You may not qualify if:

  • Inability to provide informed consent
  • No arterial line planned as part of their intraoperative care
  • Aged \< 18 years of age
  • Patients with aortic regurgitation
  • Patients fitted with an intra-aortic balloon pump (IABP)
  • No other intra-arterial pressure management system in use
  • Concurrent participation in another experimental intervention or drug study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

HypotensionIntraoperative Complications

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Clutton-Brock

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Monitored with HDA
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

November 1, 2021

Study Start

October 22, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)