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

Not Applicable

• Conditions: Management of perfusion during general anaesthesia; Anaesthesiology - Anaesthetics; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12624000713594
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients for whom complete haemodynamic data, key event data, and intervention data is available. This will be assessed as a composite outcome.[Complete haemodynamic data is defined as download and storage of a haemodynamic monitoring file; for the pressure field group, the file will be downloaded from the pressure field software, and for the control group, the file will be downloaded from the EV1000 or Hemosphere monitor. Complete event data is defined as a recorded start and end time of anaesthesia; start and end time of surgery; estimated blood loss and estimated start and end times for this; and estimated start and end time of any pneumoperitoneum or Trendelenburg or reverse Trendelenburg position. Complete intervention data is defined as recorded total fluid, blood product, inotrope, and vasoactive drug use. Event and intervention data is recorded in the case report form. At the conclusion of study.]