Hypotension Decision Assist - Use, Safety and Efficacy (HDA-USE)

A Study of the Use, Safety and Efficacy of the Hypotension Decision Assist Device

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: Monitored by HDA

Detailed Description

In this study participants who are due to undergo elective major surgery and have an arterial line as part of their standard care will be invited to have the additional monitoring device (HDA) included as part of their care. Agreeing participants will have demographic, contact and medical history information necessary to conduct the study recorded, including a record of their intraoperative arterial line measurements.

After completing the consent process participants will receive intraoperative monitoring with Hypotension Decision Assist in addition to their standard care. The HDA monitor will be attached to the patient vital signs monitor, which will in turn be attached to the blood pressure transducer. All sampled arterial line data collected by the patient vital signs monitored will be automatically transmitted in real time to the HDA device via a serial cable attached to a digital export port of the vital signs monitor. HDA will process this input data to display, in graphical and numeric format, vital signs data and physiological parameters derived from the arterial wave form data including: Mean Arterial Pressure (MAP), systolic and diastolic blood pressure, heart rate and changes in heart rate, cardiac output and systemic vascular resistance.

The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device and to evaluate whether HDA improves control of the cardiovascular system from the anaesthetists' perspective.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitored with HDA; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of intraoperative hypotension	Measured incidence of Mean Arterial Pressure < 65 for at least 1 minute	Intraoperative
Number and type of intervention made by anaesthetists	Quantification of interventions related to patient cardiovascular management including fluid administered, cardiovascular active drugs administered and or drug infusion rate changes if applicable	Intraoperative
Comparison of HDA projected trend feature	Comparison of the estimated MAP at +2mins by projected trend feature versus the observed Mean Arterial Pressure at that time as it arises.	Intraoperative
Anaesthetists evaluation of use against a five point Likert-type scale	Anaesthetists evaluation of the ease of use and usefulness of HDA ranked in accordance with a five-point Likert-type rating scale where the minimum value is 1 (strongly disagree that HDA is useful or easy to use) and the maximum is 5 (strongly agree that HDA is useful or easy to use) .	Intraoperative

Collaborators and Investigators

• Sponsor: Directed Systems Limited
• Collaborators: University Hospital Birmingham NHS Foundation Trust; Innovate UK
• Investigators: Principal Investigator: Thomas Clutton-Brock, University Hospital Birmingham NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hypotension; Intraoperative complications; Intraoperative care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: BPA-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No