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

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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
      Arterial Pressure* ; Blood Pressure Determination* ; Software*; Cardiac Surgical Procedures/*adverse effects ; Hypotension/*prevention & control ; Monitoring, Intraoperative/*methods; Female ; Humans ; Hypotension/diagnosis ; Hypotension/etiology ; Hypotension/physiopathology ; Male ; Middle Aged ; Multicenter Studies as Topic ; Ohio ; Pragmatic Clinical Trials as Topic ; Risk Factors ; Time Factors ; Treatment Outcome
    • نبذة مختصرة :
      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.
    • References:
      Anesthesiology. 2007 Aug;107(2):213-20. (PMID: 17667564)
      Anesthesiology. 2009 Dec;111(6):1217-26. (PMID: 19934864)
      Anesthesiology. 2013 Sep;119(3):507-15. (PMID: 23835589)
      Anesthesiology. 2015 Jul;123(1):79-91. (PMID: 25929547)
      Anesthesiology. 2015 Aug;123(2):307-19. (PMID: 26083768)
      Anesthesiology. 2015 Sep;123(3):515-23. (PMID: 26181335)
      J Intensive Care Med. 2016 Dec;31(10):667-675. (PMID: 26721639)
      Anesthesiology. 2017 Jan;126(1):47-65. (PMID: 27792044)
      JAMA. 2017 Apr 25;317(16):1642-1651. (PMID: 28444280)
      JAMA. 2017 Oct 10;318(14):1346-1357. (PMID: 28973220)
      Anesthesiology. 2018 Oct;129(4):663-674. (PMID: 29894315)
      Anaesthesia. 2018 Oct;73(10):1223-1228. (PMID: 30144029)
    • Grant Information:
      R01 CA092614 United States CA NCI NIH HHS
    • Molecular Sequence:
      ClinicalTrials.gov NCT03610165
    • الموضوع:
      Date Created: 20190505 Date Completed: 20191212 Latest Revision: 20200225
    • الموضوع:
      20250114
    • الرقم المعرف:
      PMC6499972
    • الرقم المعرف:
      10.1186/s13063-019-3329-0
    • الرقم المعرف:
      31053082