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Research Article: Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 – study protocol of a randomised clinical trial

Date Published: 2023-05-02

Abstract:
Introduction Hypotension is common during cardiac surgery and often persists postoperatively in the intensive care unit (ICU). Still, treatment is mainly reactive, causing a delay in its management. The Hypotension Prediction Index (HPI) can predict hypotension with high accuracy. Using the HPI combined with a guidance protocol resulted in a significant reduction in the severity of hypotension in four non-cardiac surgery trials. This randomised trial aims to evaluate the effectiveness of the HPI in combination with a diagnostic guidance protocol on reducing the occurrence and severity of hypotension during coronary artery bypass grafting (CABG) surgery and subsequent ICU admission. Methods and analysis This is a single-centre, randomised clinical trial in adult patients undergoing elective on-pump CABG surgery with a target mean arterial pressure of 65?mm Hg. One hundred and thirty patients will be randomly allocated in a 1:1 ratio to either the intervention or control group. In both groups, a HemoSphere patient monitor with embedded HPI software will be connected to the arterial line. In the intervention group, HPI values of 75 or above will initiate the diagnostic guidance protocol, both intraoperatively and postoperatively in the ICU during mechanical ventilation. In the control group, the HemoSphere patient monitor will be covered and silenced. The primary outcome is the time-weighted average of hypotension during the combined study phases. Ethics and dissemination The medical research ethics committee and the institutional review board of the Amsterdam UMC, location AMC, the Netherlands, approved the trial protocol (NL76236.018.21). No publication restrictions apply, and the study results will be disseminated through a peer-reviewed journal. Trial registration number The Netherlands Trial Register (NL9449), ClinicalTrials.gov ( NCT05821647 ).

Introduction:
Hypotension during cardiac surgery is associated with adverse outcomes, 1–6 and its occurrence frequently extends to the postoperative intensive care unit (ICU) admission. 7–9 Current hypotension management often occurs with delay due to the predominantly reactive approach, based on downward blood pressure trends. With a linear association between the duration of a mean arterial pressure (MAP) below 65?mm Hg and the occurrence of mortality in non-cardiac populations, 10 11 it is plausible that a reduction in the…

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