Hypotension Decision Assist - Use, Safety and Efficacy

Intraoperative Hypotension Clinical Trial

— HDA-USE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101590
• Other study ID #: BPA-CIP-001
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Directed Systems Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham

Sponsors (3)

Lead Sponsor	Collaborator
Directed Systems Limited	Innovate UK, University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Measurement of intraoperative hypotension	Measured incidence of Mean Arterial Pressure < 65 for at least 1 minute	Intraoperative
Secondary	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
Secondary	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
Secondary	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