Hypotension Decision Assist - Use, Safety and Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Decision Support for Intraoperative Low Blood Pressure

NCT02726620

Hypotension

COMPLETED NA

Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery

NCT05615168

Hypotension During Surgery

COMPLETED NA

Influence of the "Hypotension Probability Index" on Intraoperative and Postoperative Hypotension in ENT- and OM-Surgery

NCT04151264

Hypotension ENT Disease Acute Kidney Injury +1 more

COMPLETED NA

A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure

NCT01654835

Intraoperative Low Blood Pressure

WITHDRAWN NA

Artificial Intelligence - to Predict and Prevent Hypotension During Surgery

NCT06240234

Monitoring, Intraoperative

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraoperative Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Monitored with HDA

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Monitored by HDA

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No