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Evaluating a software-based model for improving management of the circulation of adult patients undergoing major surgery.

The pressure field: a feasibility trial of a Software-based Model for Optimisation of the Adult Circulation during Surgery (SMOACS).


Sponsor

Austin Health

Enrollment

100 participants

Start Date

Aug 28, 2024

Study Type

Interventional

Conditions

Summary

A critical part of an anaesthetist’s job is to make sure that the cells of a patient’s body continue to receive the right amount of oxygen. Oxygen delivery can't be directly measured, and anaesthetists rely on the surrogate measure of blood pressure. The pressure field software is real-time monitoring software which enables anaesthetists to understand how the heart and the body’s vessels are working together to generate blood pressure. This information, combined with a treatment algorithm, assists an anaesthetist in understanding what fluids or drugs will most help a patient. This may be particularly helpful for anaesthetists when they are caring for elderly patients, in whom it can be more challenging to know what fluids or drugs will work best. A large clinical trial evaluating the impact of the pressure field method on patient outcomes is being planned and this feasibility trial will 'road test' key elements of the planned large trial.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

During major abdominal surgery, anaesthetists must carefully manage blood pressure and fluid levels to ensure the body's organs receive enough oxygen. Traditional blood pressure monitoring has limitations — it does not clearly show whether the heart or the blood vessels are the main cause of a pressure problem. A new monitoring software called the Pressure Field method interprets blood pressure data in a way that helps anaesthetists choose the right treatment (fluids versus blood pressure drugs) more precisely. This feasibility study from Austin Health is preparing for a large future trial by testing whether the Pressure Field software and its accompanying treatment protocol can be smoothly integrated into anaesthetic care for major abdominal surgery. The focus is on making sure the study design, training, and data collection all work well before scaling up. You may be eligible as a patient if you are scheduled for an elective intermediate to high-risk abdominal procedure and your anaesthesia plan includes arterial and central venous catheters connected to specific monitoring equipment. Pregnant patients and those in other conflicting trials are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention group is the 'pressure field group'. Anaesthetists in the pressure field group will receive clinical education on the pressure field method for managing perfusion. The pressure fie

The intervention group is the 'pressure field group'. Anaesthetists in the pressure field group will receive clinical education on the pressure field method for managing perfusion. The pressure field method consists of defining a patient's baseline haemodynamic zone and defending this distinct haemodynamic zone during surgery. The education consists of two 1-hour clinical education sessions, using the pressure field software to monitor three patients undergoing surgery, and completing an online questionnaire. The content includes the physiological basis for the haemodynamic zone, the process for determining a patient’s baseline haemodynamic zone, and strategies for maintaining parameters within the zone. The zone is defined in terms of mean perfusion pressure (MPP), stroke volume (SV), and systemic elastance (Esys). The goal of intraoperative care is to maintain MPP within ±15% of the patient’s MPP baseline values without tolerating any MPP below 60 mmHg, and to maintain SV and Esys within ±15% of the patient’s baseline values. Anaesthetists will use the EV1000 or Hemosphere haemodynamic monitor, and the pressure field software, to support the management of patients. No fluids, blood products, inotropes, or vasoactive drugs are to be administered prior to commencement of FloTrac monitoring. Roller clamps on fluid lines are to be closed except where fluid is actively being used to optimise the circulation. A vasopressor infusion is to be connected to the patient prior to induction (so that it can be promptly commenced as needed). Choice and titration of fluids, blood products, inotropes, and vasopressors is otherwise at the discretion of the attending anaesthetist. Implementation scientists will measure the acceptability of the pressure field method by surveying participating anaesthetists at baseline, 6 months post-baseline, and 12 months post-baseline; assess the fidelity of intervention delivery by reviewing protocol deviations at 1, 6, and 12 months post-baseline (by auditing case report forms); and conduct semi-structured interviews with participating anaesthetists based on the Theoretical Domains Framework to identify and understand implementation barriers at 12 months post-baseline. If acceptability or intervention fidelity delivery is below 80%, enhancement strategies will be applied. Enhancement strategies may include additional clinical education or additional clinical research coordinator support in completing case report forms. Anaesthetist participants will use the pressure field method until recruitment of the target number of patient participants in the pressure field group is complete.


Locations(1)

VIC, Australia

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ACTRN12624000713594