Researchers will screen all patients who present for elective, non-cardiac surgery. Patients will be contacted by the principal investigator (PI) of each hospital and informed if they are eligible. The patient’s informed consent will be obtained the day before surgery. Patient demographics and comorbidities will be collected before randomisation. Patients will be assigned by the local PI to the intraoperative HPI algorithm (intervention group) or a GDT algorithm (control group). We will use a computer-generated, variable block randomisation method through age strata. Patients will not be aware of the group allocation. Although intraoperative personnel (anaesthesiologists, surgeons…) will be not blinded to monitoring allocation, data-analysis will remain blinded.
All PIs and collaborators will receive specific training with the monitoring used for haemodynamic management.
A Consolidated Standards of Reporting Trials flow diagram of the study is shown in figure 1. All data will be entered using an electronic Clinical Report Form in Castor EDC, a Good Clinical Practice compliant data management system.13
CONSORT flow diagram. CONSORT, Consolidated Standards of Reporting Trials.
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