EU HYPROTECT Registry

• Research type

  Research Study

• Full title

  European hypotension prediction index real world experience using Acumen TM Hypotension Prediction Index software to prevent intraoperative hypotension: The multicentre prospective observational registry.

• IRAS ID

  302375

• Contact name

  Simon Davies

• Contact email

  simon.davies@york.nhs.uk

• Sponsor organisation

  Edwards Lifesciences

• Clinicaltrials.gov Identifier

  NCT04972266, ClinicalTrials.gov

• Duration of Study in the UK

  1 years, 0 months, 13 days

• Research summary

  European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery to describe the incidence, duration, and severity of intraoperative hypotension using AcumenTM Hypotension Prediction
  Index software. Predicting hypotension using machine learning and artificial intelligence may help establishing preemptive treatment strategies and eventually avoid hypotension.
  There will be 12 centers participating across Italy, Spain, UK, Germany and France with the aim to include 700 patients in total. Data is collected over a follow up period of 30 days (or the length of hospital stay, whatever is longer). Clinical outcomes will be documented in an eCRF at baseline, procedure, discharge, 1 month (or length of hospital stay).

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  21/NE/0162

• Date of REC Opinion

  23 Aug 2021

• REC opinion

  Further Information Favourable Opinion