Abstract
BackgroundHypotension is associated with serious complications, including myocardial infarction, acute kidney injury, and mortality. Consequently, predicting and preventing hypotension may improve outcomes. We will therefore determine if use of a novel hypotension prediction tool reduces the duration and severity of hypotension in patients having non-cardiac surgery.Methods/designWe will conduct a two-center, pragmatic, randomized controlled trial (N = 213) in noncardiac surgical patients > 45 years old who require intra-arterial blood pressure monitoring. All participating patients will be connected to a Flortrac IQ sensor and EV1000 platform (Edwards Lifesciences, Irvine). They will be randomly assigned to blinded or unblinded arms. The Hypotension Prediction Index (HPI) and advanced hemodynamic information will be universally recorded, but will only be available to clinicians when patients are assigned to unblinded monitoring. The primary outcome will be the effect of HPI software guidance on intraoperative time-weighted average mean arterial pressure under a threshold of 65 mmHg, which will be assessed with a Wilcoxon-Mann-Whitney 2-sample, two-tailed test.DiscussionOur trial will determine whether the Hypotension Prediction Index and associated hemodynamic information substantively reduces hypotension during non-cardiac surgery.Trial registrationClinicalTrials.gov, NCT03610165. Registered on 1 August 2018.
Highlights
Hypotension is associated with serious complications, including myocardial infarction, acute kidney injury, and mortality
We propose to compare the amount of intraoperative hypotension below a mean arterial pressure (MAP) of 65 mmHg in patients requiring invasive arterial pressure monitoring who are randomized to blinded vs unblinded Hypotension Prediction Index (HPI) monitoring
Methods/design We will conduct a trial comparing the amount of hypotension in patients requiring invasive arterial pressure monitoring and randomized to blinded vs unblinded HPI monitoring (Fig. 1)
Summary
Hypotension is associated with serious complications, including myocardial infarction, acute kidney injury, and mortality. Predicting and preventing hypotension may improve outcomes. We will determine if use of a novel hypotension prediction tool reduces the duration and severity of hypotension in patients having non-cardiac surgery. Most patients having non-cardiac surgery experience at least one episode during which mean arterial pressure (MAP) decreases to < 65 mmHg, often shortly after anesthetic induction [2, 3]. Intraoperative hypotension is associated with complications, including myocardial infarction, acute kidney injury, and mortality [4,5,6,7]. It seems likely that reducing the frequency, depth, and duration of intraoperative hypotension will reduce organ injury. It is difficult to predict, and prevent, intraoperative hypotension
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