Clinical trial NCT05101590: Hypotension Decision Assist - Use, Safety and Efficacy
Official title: A Study of the Use, Safety and Efficacy of the Hypotension Decision Assist Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Keywords: Hypotension
Intraoperative care
Intraoperative complications
Lead sponsor: Directed Systems Limited
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Birmingham NHS Foundation Trust
name: Innovate UK
First posted: 2021-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monitored with HDA
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Display of trends in mean arterial pressure measured in millimetres of mercury (mmHg)
timeFrame: Intraoperative
measure: Display of trends in systolic blood pressure measured in millimetres of mercury (mmHg)
timeFrame: Intraoperative
measure: Display of trends in diastolic blood pressure measured in millimetres of mercury (mmHg)
timeFrame: Intraoperative
measure: Display of trends in heart rate measured in beats per minute (bpm)
timeFrame: Intraoperative
measure: Display of trends of changes in heart rate (percentage) over the previous five minutes measured as a percentage
timeFrame: Intraoperative
measure: Display of trends of changes in cardiac output (percentage) over the previous five minutes measured as a percentage
timeFrame: Intraoperative
measure: Display of trends of changes in systemic vascular resistance (percentage) over the previous five minutes measured as a percentage
timeFrame: Intraoperative
measure: Adverse events (AEs) related to blood pressure attributable to HDA
timeFrame: Intraoperative
Secondary outcomes:
measure: Measurement of intraoperative hypotension
timeFrame: Intraoperative
measure: Number and type of intervention made by anaesthetists
timeFrame: Intraoperative
measure: Comparison of HDA projected trend feature
timeFrame: Intraoperative
measure: Anaesthetists evaluation of use against a five point Likert-type scale
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Thomas Clutton-Brock
role: PRINCIPAL_INVESTIGATOR
References: