Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial

Abstract

The “Hypotension Prediction Index (HPI)” represents a newly introduced monitoring-tool that aims to predict episodes of intraoperative hypotension (IOH) before their occurrence. In order to evaluate the feasibility of protocolized care according to HPI monitoring, we hypothesized that HPI predicts the incidence of IOH and reduces the incidence and duration of IOH. This single centre feasibility randomised blinded prospective interventional trial included at total of 99 patients. One group was managed by goal-directed therapy algorithm based on HPI (HPI, n = 25), which was compared to a routine anaesthetic care cohort (CTRL, n = 24) and a third historic control group (hCTRL, n = 50). Primary endpoints included frequency (n)/h, absolute and relative duration (t (min)/% of total anaesthesia time) of IOH. Significant reduction of intraoperative hypotension was recorded in the HPI group compared to the control groups (HPI 48%, CTRL 87.5%, hCTRL 80%; HPI vs. CTRL, respectively hCTRL p < 0.001). Perioperative quantity of IOH was significantly reduced in the interventional group compared to both other study groups (HPI: 0 (0–1), CTRL: 5 (2–6), hCTRL: 2 (1–3); p < 0.001). Same observations were identified for absolute (HPI: 0 (0–140) s, CTRL: 640 (195–1315) s, hCTRL 660 (180–1440) s; p < 0.001) and relative duration of hypotensive episodes (minutes MAP ≤ 65 mmHg in  % of total anaesthesia time; HPI: 0 (0–1), CTRL: 6 (2–12), hCTRL 7 (2–17); p < 0.001). The HPI algorithm combined with a protocolized treatment was able to reduce the incidence and duration of hypotensive events in patients undergoing primary hip arthroplasty.

Trial registration: NCT03663270.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

References

  1. 1.

    van Waes JAR, van Klei WA, Wijeysundera DN, van Wolfswinkel L, Lindsay TF, Beattie WS. Association between intraoperative hypotension and myocardial injury after vascular surgery. Anesthesiology. 2016;124:35–44.

    Article  Google Scholar 

  2. 2.

    Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping STJ, Bentt DR, et al. Association between Intraoperative hypotension and hypertension and 30-day postoperative mortality in noncardiac surgery. Anesthesiology. 2015;123:307–19.

    Article  Google Scholar 

  3. 3.

    Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, et al. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013;119:507–15.

    Article  Google Scholar 

  4. 4.

    Statistisches Bundesamt. Fallpauschalenbezogene Krankenhausstatistik (DRG-Statistik) Operationen und Prozeduren der vollstationären Patientinnen und Patienten in Krankenhäusern. 2016. https://www.destatis.de/DE/Publikationen/Thematisch/Gesundheit/Krankenhaeuser/OperationenProzeduren5231401157014.pdf?__blob=publicationFile. Accessed 4 Sep 2018

  5. 5.

    Hwang SK. Experience of complications of hip arthroplasty. Hip Pelvis. 2014;26:207–13.

    Article  Google Scholar 

  6. 6.

    Mantilla CB, Horlocker TT, Schroeder DR, Berry DJ, Brown DL. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology. 2002;96:1140–6.

    Article  Google Scholar 

  7. 7.

    Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an arterial waveform analysis-derived hypotension prediction index to predict future hypotensive events in surgical patients. Anesth Analg. 2019. https://doi.org/10.1213/ANE.0000000000004121.

    Article  Google Scholar 

  8. 8.

    Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, et al. Machine-learning algorithm to predict hypotension based on high-fidelity arterial pressure waveform analysis. Anesthesiology. 2018;129:663–74.

    Article  Google Scholar 

  9. 9.

    Ahmad T, Beilstein CM, Aldecoa C, Moreno RP, Molnár Z, Novak-Jankovic V, et al. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med. 2015;4:8.

    Article  Google Scholar 

  10. 10.

    Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015;351:h4672.

    Article  Google Scholar 

  11. 11.

    Le Manach Y, Collins G, Rodseth R, Le Bihan-Benjamin C, Biccard B, Riou B, et al. preoperative score to predict postoperative mortality (POSPOM): derivation and validation. Anesthesiology. 2016;124:570–9.

    Article  Google Scholar 

  12. 12.

    Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, et al. Defining an intraoperative hypotension threshold in association with stroke in cardiac surgery. Anesthesiology. 2018;129:440–7.

    Article  Google Scholar 

  13. 13.

    Franck M, Radtke FM, Prahs C, Seeling M, Papkalla N, Wernecke K-D, et al. Documented intraoperative hypotension according to the three most common definitions does not match the application of antihypotensive medication. J Int Med Res. 2012;39:846–56.

    Article  Google Scholar 

  14. 14.

    Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vásquez SM, et al. Period-dependent Associations between hypotension during and for four days after noncardiac surgery and a composite of myocardial infarction and death: a substudy of the POISE-2 trial. Anesthesiology. 2018;128:317–27.

    Article  Google Scholar 

  15. 15.

    Vernooij LM, van Klei WA, Machina M, Pasma W, Beattie WS, Peelen LM. Different methods of modelling intraoperative hypotension and their association with postoperative complications in patients undergoing non-cardiac surgery. Br J Anaesth. 2018;120:1080–9.

    CAS  Article  Google Scholar 

  16. 16.

    Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018;121:706–21.

    CAS  Article  Google Scholar 

  17. 17.

    Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, et al. Relationship between intraoperative hypotension, defined by either reduction from baseline or absolute thresholds, and acute kidney and myocardial injury after noncardiac surgery: a retrospective cohort analysis. Anesthesiology. 2017;126:47–65.

    Article  Google Scholar 

  18. 18.

    Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005;100:4–10.

    Article  Google Scholar 

  19. 19.

    Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, et al. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005;101:622–8.

    Article  Google Scholar 

  20. 20.

    Morris RW, Watterson LM, Westhorpe RN, Webb RK. Crisis management during anaesthesia: hypotension. Qual Saf Health Care. 2005;14:e11.

    CAS  Article  Google Scholar 

  21. 21.

    Edwards L. Acumen Hypotension Prediction Index software. https://www.edwards.com/devices/decision-software/hpi. Accessed 8 Oct 2018

  22. 22.

    Hallqvist L, Mårtensson J, Granath F, Sahlén A, Bell M. Intraoperative hypotension is associated with myocardial damage in noncardiac surgery: an observational study. Eur J Anaesthesiol. 2016;33:450–6.

    Article  Google Scholar 

  23. 23.

    Bijker JB, Persoon S, Peelen LM, Moons KGM, Kalkman CJ, Kappelle LJ, et al. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012;116:658–64.

    Article  Google Scholar 

  24. 24.

    Hsieh JK, Dalton JE, Yang D, Farag ES, Sessler DI, Kurz AM. The association between mild intraoperative hypotension and stroke in general surgery patients. Anesth Analg. 2016;123:933–9.

    Article  Google Scholar 

  25. 25.

    Vasivej T, Sathirapanya P, Kongkamol C. Incidence and risk factors of perioperative stroke in noncardiac, and nonaortic and its major branches surgery. J Stroke Cerebrovasc Dis. 2016;25:1172–6.

    Article  Google Scholar 

  26. 26.

    Yadeau JT, Casciano M, Liu SS, Edmonds CR, Gordon M, Stanton J, et al. Stroke, regional anesthesia in the sitting position, and hypotension: a review of 4169 ambulatory surgery patients. Reg Anesth Pain Med. 2011;36:430–5.

    Article  Google Scholar 

  27. 27.

    Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, et al. Defining an intraoperative hypotension threshold in association with stroke in cardiac surgery. Anesthesiology. 2018;129:140–4.

    Google Scholar 

  28. 28.

    Scholz AFM, Oldroyd C, McCarthy K, Quinn TJ, Hewitt J. Systematic review and meta-analysis of risk factors for postoperative delirium among older patients undergoing gastrointestinal surgery. Br J Surg. 2016;103:e21–8.

    CAS  Article  Google Scholar 

  29. 29.

    Sun LY, Wijeysundera DN, Ph D, Tait GA, Ph D, Beattie WS, et al. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. J Am Soc Anesthesiol. 2017;123:515–23.

    Article  Google Scholar 

  30. 30.

    Weinstein SM, YaDeau JT, Memtsoudis SG. Lack of association between levels and length of intraoperative controlled hypotension and acute kidney injury in total hip arthroplasty patients receiving neuraxial anesthesia. Reg Anesth Pain Med. 2018;43:725–31.

    PubMed  Google Scholar 

  31. 31.

    Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KGM, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007;107:213–20.

    Article  Google Scholar 

  32. 32.

    Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KGM, et al. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009;111:1217–26.

    Article  Google Scholar 

  33. 33.

    Kind SL, Spahn-Nett GH, Emmert MY, Eismon J, Seifert B, Spahn DR, et al. Is dilutional coagulopathy induced by different colloids reversible by replacement of fibrinogen and factor xiii concentrates? Anesth Analg. 2013;117:1063–71.

    CAS  Article  Google Scholar 

  34. 34.

    Kozek-Langenecker SA. Influence of fluid therapy on the haemostatic system of intensive care patients. Best Pract Res Clin Anaesthesiol. 2009;23:225–36.

    CAS  Article  Google Scholar 

  35. 35.

    Niemi TT, Suojaranta-Ylinen RT, Kukkonen SI, Kuitunen AH. Gelatin and hydroxyethyl starch, but not albumin, impair hemostasis after cardiac surgery. Anesth Analg. 2006;102:998–1006.

    CAS  Article  Google Scholar 

  36. 36.

    Vincent J-L, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, et al. Clinical review: update on hemodynamic monitoring–a consensus of 16. Crit Care. 2011;15:229.

    Article  Google Scholar 

  37. 37.

    Cannesson M, Pestel G, Ricks C, Hoeft A, Perel A. Hemodynamic monitoring and management in patients undergoing high risk surgery: a survey among North American and European anesthesiologists. Crit Care. 2011;15(4):R197.

    Article  Google Scholar 

  38. 38.

    Biancofiore G, Cecconi M, Della Rocca G. A web-based Italian survey of current trends, habits and beliefs in hemodynamic monitoring and management. J Clin Monit Comput. 2015;29:635–42.

    Article  Google Scholar 

Download references

Funding

This study was funded by an unrestricted research grant of Edward Lifesciences (Irvine, USA). Edwards Lifesciences was not involved in the design of this study, data generation or analysis nor writing of the manuscript.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Emmanuel Schneck.

Ethics declarations

Conflict of interest

M. Sander is a consultant for Edwards Lifesciences and Medtronic. E. Schneck and M. Habicher are consultants for Edwards Lifesciences. All other authors declare that they have no conflict of interest.

Ethical approval

The trial was designed according to the guidelines of consolidated standards of reporting trials (CONSORT), approved by the local ethics committee (University of Giessen, No. 09/17) and registered at ClincalTrials.gov (Registration No. NCT03663270).

Research involving human participants and/or animals

This article does not contain any studies with animals performed by any of the authors.

Informed consent

All prospective patients gave informed consent and retrospective data were anonymized.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Schneck, E., Schulte, D., Habig, L. et al. Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial. J Clin Monit Comput 34, 1149–1158 (2020). https://doi.org/10.1007/s10877-019-00433-6

Download citation

Keywords

  • Hypotension
  • Intraoperative hypotension
  • Goal-directed therapy
  • Hypotension Prediction Index
  • Total hip arthroplasty