Dataset Information

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial.

ABSTRACT:

Background

Hypotension 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/design

We 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.

Discussion

Our trial will determine whether the Hypotension Prediction Index and associated hemodynamic information substantively reduces hypotension during non-cardiac surgery.

Trial registration

ClinicalTrials.gov, NCT03610165 . Registered on 1 August 2018.

SUBMITTER: Maheshwari K

PROVIDER: S-EPMC6499972 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial.

Maheshwari Kamal K Shimada Tetsuya T Fang Jonathan J Ince Ilker I Mascha Edward J EJ Turan Alparslan A Kurz Andrea A Sessler Daniel I DI

Trials 20190503 1

<h4>Background</h4>Hypotension 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.<h4>Methods/design</h4>We will conduct a two-center, pragmatic, randomized controlled trial (N = 213) in noncardiac surgic ...[more]

PMID: 31053082

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Project description:BackgroundIntraoperative hypotension is common during noncardiac surgery and is associated with postoperative myocardial infarction, acute kidney injury, stroke, and severe infection. The Hypotension Prediction Index software is an algorithm based on arterial waveform analysis that alerts clinicians of the patient's likelihood of experiencing a future hypotensive event, defined as mean arterial pressure < 65 mmHg for at least 1 min.MethodsTwo analyses included (1) a prospective, single-arm trial, with continuous blood pressure measurements from study monitors, compared to a historical comparison cohort. (2) A post hoc analysis of a subset of trial participants versus a propensity score-weighted contemporaneous comparison group, using external data from the Multicenter Perioperative Outcomes Group (MPOG). The trial included 485 subjects in 11 sites; 406 were in the final effectiveness analysis. The post hoc analysis included 457 trial participants and 15,796 comparison patients. Patients were eligible if aged 18 years or older, American Society of Anesthesiologists (ASA) physical status 3 or 4, and scheduled for moderate- to high-risk noncardiac surgery expected to last at least 3 h.Measurementsminutes of mean arterial pressure (MAP) below 65 mmHg and area under MAP < 65 mmHg.ResultsAnalysis 1: Trial subjects (n = 406) experienced a mean of 9 ± 13 min of MAP below 65 mmHg, compared with the MPOG historical control mean of 25 ± 41 min, a 65% reduction (p < 0.001). Subjects with at least one episode of hypotension (n = 293) had a mean of 12 ± 14 min of MAP below 65 mmHg compared with the MPOG historical control mean of 28 ± 43 min, a 58% reduction (p< 0.001). Analysis 2: In the post hoc inverse probability treatment weighting model, patients in the trial demonstrated a 35% reduction in minutes of hypotension compared to a contemporaneous comparison group [exponentiated coefficient: - 0.35 (95%CI - 0.43, - 0.27); p < 0.001].ConclusionsThe use of prediction software for blood pressure management was associated with a clinically meaningful reduction in the duration of intraoperative hypotension. Further studies must investigate whether predictive algorithms to prevent hypotension can reduce adverse outcomes.Trial registrationClinical trial number: NCT03805217. Registry URL: https://clinicaltrials.gov/ct2/show/NCT03805217 . Principal investigator: Xiaodong Bao, MD, PhD. Date of registration: January 15, 2019.

Project description:Background: Intraoperative hypotension is common in patients having non-cardiac surgery and associated with postoperative acute myocardial injury, acute kidney injury, and mortality. Avoiding intraoperative hypotension is a complex task for anesthesiologists. Using artificial intelligence to predict hypotension from clinical and hemodynamic data is an innovative and intriguing approach. The AcumenTM Hypotension Prediction Index (HPI) software (Edwards Lifesciences; Irvine, CA, USA) was developed using artificial intelligence—specifically machine learning—and predicts hypotension from blood pressure waveform features. We aimed to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery. Methods: We built up a European, multicenter, prospective, observational registry including at least 700 evaluable patients from five European countries. The registry includes consenting adults (≥18 years) who were scheduled for elective major non-cardiac surgery under general anesthesia that was expected to last at least 120 min and in whom arterial catheter placement and HPI monitoring was planned. The major objectives are to quantify and characterize intraoperative hypotension (defined as a mean arterial pressure [MAP] < 65 mmHg) when using HPI monitoring. This includes the time-weighted average (TWA) MAP < 65 mmHg, area under a MAP of 65 mmHg, the number of episodes of a MAP < 65 mmHg, the proportion of patients with at least one episode (1 min or more) of a MAP < 65 mmHg, and the absolute maximum decrease below a MAP of 65 mmHg. In addition, we will assess causes of intraoperative hypotension and investigate associations between intraoperative hypotension and postoperative outcomes. Discussion: There are only sparse data on the effect of using HPI monitoring on intraoperative hypotension in patients having elective major non-cardiac surgery. Therefore, we built up a European, multicenter, prospective, observational registry to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery.

Project description:IntroductionAbdominal oncologic surgeries pose significant risks due to the complexity of the surgery and patients' often weakened health, multiple comorbidities, and increased perioperative hazards. Hypotension is a major risk factor for perioperative cardiovascular complications, necessitating individualized management in modern anesthesiology.AimThis study aimed to determine the dynamics of changes in troponin and NTproBNP levels during the first two postoperative days in patients undergoing major cancer abdominal surgery with advanced hemodynamic monitoring including The AcumenTM Hypotension Prediction Index software (HPI) (Edwards Lifesciences, Irvine, CA, USA) and their association with the occurrence of postoperative cardiovascular complications.MethodsA prospective study was conducted, including 50 patients scheduled for abdominal cancer surgery who, due to the overall risk of perioperative complications (ASA class 3 or 4), were monitored using the HPI software. Hypotension was qualified as at least one ≥ 1 min episode of a MAP < 65 mm Hg. Preoperatively and 24 and 48 h after the procedure, the levels of NTproBNP and troponin were measured, and an ECG was performed.ResultsWe analyzed data from 46 patients and found that 82% experienced at least one episode of low blood pressure (MAP < 65 mmHg). However, the quality indices of hypotension were low, with a median time-weighted average MAP < 65 mmHg of 0.085 (0.03-0.19) mmHg and a median of 2 (2-1.17) minutes spent below MAP < 65 mmHg. Although the incidence of perioperative myocardial injury was 10%, there was no evidence to suggest a relationship with hypotension. Acute kidney injury was seen in 23.9% of patients, and it was significantly associated with a number of episodes of MAP < 50 mmHg. Levels of NTproBNP were significantly higher on the first postoperative day compared to preoperative values (285.8 [IQR: 679.8] vs. 183.9 [IQR: 428.1] pg/mL, p < 0.001). However, they decreased on the second day (276.65 [IQR: 609.4] pg/mL, p = 0.154). The dynamics of NTproBNP were similar for patients with and without heart failure, although those with heart failure had significantly higher preoperative concentrations (435.9 [IQR: 711.15] vs. 87 [IQR: 232.2] pg/mL, p < 0.001). Patients undergoing laparoscopic surgery showed a statistically significant increase in NTproBNP.ConclusionsThis study suggests that advanced HPI monitoring in abdominal cancer surgery effectively minimizes intraoperative hypotension with no significant NTproBNP or troponin perioperative dynamics, irrespective of preoperative heart failure.

Project description:BackgroundIntraoperative hypotension (IOH) occurs frequently during surgery and may be associated with organ ischemia; however, few multicenter studies report data regarding its associations with adverse postoperative outcomes across varying hemodynamic thresholds. Additionally, no study has evaluated the association between IOH exposure and adverse outcomes among patients by various age groups.MethodsA multicenter retrospective cohort study was conducted between 2008 and 2017 using intraoperative blood pressure data from the US electronic health records database to examine postoperative outcomes. IOH was assessed in 368,222 noncardiac surgical procedures using 5 methods: (a) absolute maximum decrease in mean arterial pressure (MAP) during surgery, (b) time under each absolute threshold, (c) total area under each threshold, (d) time-weighted average MAP under each threshold, and (e) cumulative time under the prespecified relative MAP thresholds. MAP thresholds were defined by absolute limits (≤75, ≤65, ≤55 mm Hg) and by relative limits (20% and 40% lower than baseline). The primary outcome was major adverse cardiac or cerebrovascular events; secondary outcomes were all-cause 30- and 90-day mortality, 30-day acute myocardial injury, and 30-day acute ischemic stroke. Residual confounding was minimized by controlling for observable patient and surgical factors. In addition, we stratified patients into age subgroups (18-40, 41-50, 51-60, 61-70, 71-80, >80) to investigate how the association between hypotension and the likelihood of major adverse cardiac or cerebrovascular events and acute kidney injury differs in these age subgroups.ResultsIOH was common with at least 1 reading of MAP ≤75 mm Hg occurring in 39.5% (145,743) of cases; ≤65 mm Hg in 19.3% (70,938) of cases, and ≤55 mm Hg in 7.5% (27,473) of cases. IOH was significantly associated with the primary outcome for all age groups. For an absolute maximum decrease, the estimated odds of a major adverse cardiac or cerebrovascular events in the 30-day postsurgery was increased by 12% (95% confidence interval [CI], 11-14) for ≤75 mm Hg; 17.0% (95% CI, 15-19) for ≤65 mm Hg; and by 26.0% (95% CI, 22-29) for ≤55 mm Hg.ConclusionsIOH during noncardiac surgery is common and associated with increased 30-day major adverse cardiac or cerebrovascular events. This observation is magnified with increasing hypotension severity. The potentially avoidable nature of the hazard, and the extent of the exposed population, makes hypotension in the operating room a serious public health issue that should not be ignored for any age group.

Project description:(1) Background: The Hypotension Prediction Index (HPI) is an algorithm that predicts hypotension, defined as mean arterial pressure (MAP) less than 65 mmHg for at least 1 min, based on arterial waveform features. We tested the hypothesis that the use of this index reduces the duration and severity of hypotension during noncardiac surgery. (2) Methods: We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized 1:1 to standard of care or hemodynamic management with HPI guidance with a goal directed hemodynamic treatment protocol. The trigger to initiate treatment (with fluids, vasopressors, or inotropes) was a value of HPI of 85 (range, 0-100) or higher in the intervention group. Primary outcome was the amount of hypotension, defined as time-weighted average (TWA) MAP less than 65 mmHg. Secondary outcomes were time spent in hypertension defined as MAP more than 100 mmHg for at least 1 min; medication and fluids administered and postoperative complications. (3) Results: We obtained data from 99 patients. The median (IQR) TWA of hypotension was 0.16 mmHg (IQR, 0.01-0.32 mmHg) in the intervention group versus 0.50 mmHg (IQR, 0.11-0.97 mmHg) in the control group, for a median difference of -0.28 (95% CI, -0.48 to -0.09 mmHg; p = 0.0003). We also observed an increase in hypertension in the intervention group as well as a higher weight-adjusted administration of phenylephrine in the intervention group. (4) Conclusions: In this single-center prospective study of patients undergoing elective noncardiac surgery, the use of this prediction model resulted in less intraoperative hypotension compared with standard care. An increase in the time spent in hypertension in the treatment group was also observed, probably as a result of overtreatment. This should provide an insight for refining the use of this prediction index in future studies to avoid excessive correction of blood pressure.

Dataset Information

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial.

Background

Methods/design

Discussion

Trial registration

Publications

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial.

Similar Datasets

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