{"id":"AIBD-0636","title":"HYPE randomized trial at Amsterdam UMC: the Hypotension Prediction Index with a treatment protocol cuts intraoperative hypotension","summary":"In the HYPE trial at Amsterdam UMC, the Hypotension Prediction Index cut median time in hypotension during surgery from 32.7 to 8.0 minutes per patient.","date_observed":"2019-03-01","date_basis":"event","date_precision":"month","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Anesthesiologists at Amsterdam UMC (location AMC) in the Netherlands ran the HYPE randomized trial among adults having elective noncardiac surgery under general anesthesia with invasive blood pressure monitoring, enrolled from May 2018 to March 2019. In the intervention group, clinicians used the Hypotension Prediction Index, a machine learning early warning system from Edwards Lifesciences that predicts hypotension from the arterial waveform, together with a diagnostic and treatment protocol. Of 68 randomized patients, 60 completed the trial. The median time-weighted average of hypotension fell from 0.44 to 0.10 mm Hg, and median time in hypotension fell from 32.7 to 8.0 minutes per patient. The trial was small and ran at one center, and it measured a physiological outcome with no clinical outcome. Edwards Lifesciences funded the trial; the authors report that the company took no part in its design, analysis or reporting. In 2023, anesthesiologists at University Hospital Dubrava in Zagreb, Croatia, who received no outside funding, reported that the index also reduced the number and duration of hypotensive episodes in 34 patients having thoracic surgery.","category":"general benefit","unexpected":false,"purpose":"The index was built to predict hypotension minutes before it happens so that clinicians can prevent it. Less hypotension was that purpose.","system":"Hypotension Prediction Index (HPI)","model_version":null,"developer":"Edwards Lifesciences","deployer":"Amsterdam UMC, location AMC","location":"Amsterdam UMC, location AMC, Amsterdam, the Netherlands","domain":"Healthcare","segment":null,"benefit_type":"Reduced Risk","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"personal","depth":2,"reason":"Median time in hypotension per patient fell from 32.7 to 8.0 minutes during surgery."}],"ai_role":{"status":"assessed","statement":"Patients were randomized to the early warning system with a protocol or to standard care, so the trial isolates the effect of the system and its protocol together."},"evidence":[{"kind":"peer-reviewed study","citation":"Wijnberge M, Geerts BF, Hol L, et al. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020;323(11):1052-1060.","title":"Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7078808/","date":"2020-02-17","written_by":"makers","quote":"The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group"},{"kind":"peer-reviewed study","citation":"Šribar A, Jurinjak IS, Almahariq H, et al. Hypotension prediction index guided versus conventional goal directed therapy to reduce intraoperative hypotension during thoracic surgery: a randomized trial. BMC Anesthesiol. 2023;23:101.","title":"Hypotension prediction index guided versus conventional goal directed therapy to reduce intraoperative hypotension during thoracic surgery: a randomized trial","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10061960/","date":"2023-03-30","written_by":"independent","quote":"In the studied cohort, use of machine learning algorithm guided hemodynamic optimization (HPI) significantly reduced the number and duration of intraoperative hypotensive episodes, as well as AUT and the primary outcome-TWA of AUT."}],"replication":{"produced_by":["Clinicians received the index together with a hemodynamic diagnostic guidance and treatment protocol.","Patients had invasive arterial blood pressure monitoring."],"must_hold":["Clinicians must act on alerts with the protocol.","Patients must have arterial waveform monitoring."],"echoes":[{"date":"2023-03-30","setting":"Esophageal or lung resection at University Hospital Dubrava, Zagreb, Croatia (34 patients, no outside funding)","model_version":null,"outcome":"recurred","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10061960/"},{"date":"2023-02-01","setting":"Elective cardiac surgery and ICU stay at an academic hospital in the Netherlands (HYPE-2 trial, same research group)","model_version":null,"outcome":"recurred","source":"https://pubmed.ncbi.nlm.nih.gov/39576150/"},{"date":"2020-12-01","setting":"Moderate- to high-risk noncardiac surgery, pilot randomized trial of index guidance","model_version":null,"outcome":"did not recur","source":"https://pubmed.ncbi.nlm.nih.gov/32960954/"}]},"paired_incident":null,"headline":"An early warning helps Amsterdam anesthetists keep blood pressure up","metric":"median time in hypotension fell from 32.7 to 8.0 minutes per patient","comparator":{"against":"Standard care with the same blood pressure goal","before":"32.7 minutes median time in hypotension per patient","after":"8.0 minutes median time in hypotension per patient","basis":"measured","quote":"The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7078808/"},"later":{"status":"challenged","date":"2020-12-01","note":"A pilot randomized trial of index guidance in moderate- to high-risk noncardiac surgery found no reduction in hypotension.","quote":"Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg.","url":"https://pubmed.ncbi.nlm.nih.gov/32960954/"},"value":null,"developer_country":"United States","deployer_country":"Netherlands","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7078808/","editor":"AIBD"}],"confidence":"studied","shade":"high","claim_status":"Independently studied","claim_basis":"Sources: one independent peer-reviewed study and the makers' peer-reviewed study. 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