None listed
Conditions
Brief 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.
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 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 onlin
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Anaesthetists: consultant anaesthetists who are regular users of advanced haemodynamic monitoring and who regularly provide anaesthetic care for major intra-abdominal surgery at a trial site. Patients: scheduled for an elective intermediate- to high-risk abdominal surgical procedure and expected to be managed using a peripheral arterial catheter and central venous catheter connected to an EV1000 or Hemosphere monitor.
Exclusion criteria
Anaesthetists: Anaesthetists who do not expect to be regularly providing care for major intra-abdominal surgery throughout the trial period. Patients: Pregnancy or participation in a conflicting interventional clinical trial.
Outcome results
None listed