{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:30:05Z","timestamp":1760059805369,"version":"build-2065373602"},"reference-count":22,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T00:00:00Z","timestamp":1752624000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Edwards Lifesciences","award":["PCORI EASCS-34606"],"award-info":[{"award-number":["PCORI EASCS-34606"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Hypotension following epidural labor analgesia (ELA) is its most common complication, affecting approximately 20% of patients and posing risks to both maternal and fetal health. As digital tools and predictive analytics increasingly shape perioperative and obstetric anesthesia practices, real-world implementation data are needed to guide their integration into clinical care. Current monitoring practices rely on intermittent non-invasive blood pressure (NIBP) measurements, which may delay recognition and treatment of hypotension. The Hypotension Prediction Index (HPI) algorithm uses continuous arterial waveform monitoring to predict hypotension for potentially earlier intervention. This clinical trial evaluated the feasibility, acceptability, and efficacy of continuous HPI-guided treatment in reducing time-to-treatment for ELA-associated hypotension and improving maternal hemodynamics. Methods: This was a prospective randomized controlled trial design involving healthy pregnant individuals receiving ELA. Participants were randomized into two groups: Group CM (conventional monitoring with NIBP) and Group HPI (continuous noninvasive blood pressure monitoring). In Group HPI, hypotension treatment was guided by HPI output; in Group CM, treatment was based on NIBP readings. Feasibility, appropriateness, and acceptability outcomes were assessed among subjects and their bedside nurse using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instruments. The primary efficacy outcome was time-to-treatment of hypotension, defined as the duration between onset of hypotension and administration of a vasopressor or fluid therapy. This outcome was chosen to evaluate the clinical responsiveness enabled by HPI monitoring. Hypotension is defined as a mean arterial pressure (MAP) &lt; 65 mmHg for more than 1 min in Group CM and an HPI threshold &lt; 75 for more than 1 min in Group HPI. Secondary outcomes included total time in hypotension, vasopressor doses, and hemodynamic parameters. Results: There were 30 patients (Group HPI, n = 16; Group CM, n = 14) included in the final analysis. Subjects and clinicians alike rated the acceptability, appropriateness, and feasibility of the continuous monitoring device highly, with median scores \u2265 4 across all domains, indicating favorable perceptions of the intervention. The cumulative probability of time-to-treatment of hypotension was lower by 75 min after ELA initiation in Group HPI (65%) than Group CM (71%), although this difference was not statistically significant (log-rank p = 0.66). Mixed models indicated trends that Group HPI had higher cardiac output (\u03b2 = 0.58, 95% confidence interval \u22120.18 to 1.34, p = 0.13) and lower systemic vascular resistance (\u03b2 = \u221297.22, 95% confidence interval \u2212200.84 to 6.40, p = 0.07) throughout the monitoring period. No differences were found in total vasopressor use or intravenous fluid administration. Conclusions: Continuous monitoring and precision hypotension treatment is feasible, appropriate, and acceptable to both patients and clinicians in a labor and delivery setting. These hypothesis-generating results support that HPI-guided treatment may be associated with hemodynamic trends that warrant further investigation to determine definitive efficacy in labor analgesia contexts.<\/jats:p>","DOI":"10.3390\/jcm14145037","type":"journal-article","created":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T15:48:22Z","timestamp":1752680902000},"page":"5037","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility of Hypotension Prediction Index-Guided Monitoring for Epidural Labor Analgesia: A Randomized Controlled Trial"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8049-9531","authenticated-orcid":false,"given":"Okechukwu","family":"Aloziem","sequence":"first","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8559-9830","authenticated-orcid":false,"given":"Hsing-Hua Sylvia","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kourtney","family":"Kelly","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8932-5802","authenticated-orcid":false,"given":"Alexandra","family":"Nicholas","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan C.","family":"Romeo","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6889-3747","authenticated-orcid":false,"given":"C. Tyler","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-6664-6342","authenticated-orcid":false,"given":"Ximiao","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8013-0080","authenticated-orcid":false,"given":"Grace","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"},{"name":"Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA"},{"name":"UPMC Magee, 300 Halket Street, Suite 3403, Pittsburgh, PA 15213, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"(2016). Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology, 124, 270\u2013300.","DOI":"10.1097\/ALN.0000000000000935"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e01174","DOI":"10.1213\/XAA.0000000000001174","article-title":"Check the Blood Pressure!: An Educational Tool for Anesthesiology Trainees Converting Epidural Labor Analgesia to Cesarean Delivery Anesthesia","volume":"14","author":"Zheng","year":"2020","journal-title":"A A Pract."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1097\/ALN.0b013e3181b437e0","article-title":"Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery","volume":"111","author":"Dyer","year":"2009","journal-title":"Anesthesiology"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"663","DOI":"10.1097\/ALN.0000000000002300","article-title":"Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis","volume":"129","author":"Hatib","year":"2018","journal-title":"Anesthesiology"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1325","DOI":"10.1007\/s10877-021-00763-4","article-title":"Hypotension Prediction Index with non-invasive continuous arterial pressure waveforms (ClearSight): Clinical performance in Gynaecologic Oncologic Surgery","volume":"36","author":"Frassanito","year":"2022","journal-title":"J. Clin. Monit. Comput."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1213\/ANE.0000000000005754","article-title":"Performance of the Hypotension Prediction Index with Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia","volume":"134","author":"Frassanito","year":"2022","journal-title":"Anesth. Analg."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"822","DOI":"10.1007\/s00540-018-2560-2","article-title":"Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: A randomized-controlled study","volume":"32","author":"Juri","year":"2018","journal-title":"J. Anesth."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1007\/s10877-020-00463-5","article-title":"Performance of the Hypotension Prediction Index with non-invasive arterial pressure waveforms in non-cardiac surgical patients","volume":"35","author":"Maheshwari","year":"2021","journal-title":"J. Clin. Monit. Comput."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Helmer, P., Helf, D., Sammeth, M., Winkler, B., Hottenrott, S., Meybohm, P., and Kranke, P. (2022). The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight(\u00ae)) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. J. Clin. Med., 11.","DOI":"10.3390\/jcm11154498"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1213\/ANE.0000000000004121","article-title":"Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients","volume":"130","author":"Davies","year":"2020","journal-title":"Anesth. Analg."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"294","DOI":"10.1186\/s13054-022-04173-z","article-title":"Effective hemodynamic monitoring","volume":"26","author":"Pinsky","year":"2022","journal-title":"Crit. Care"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Sidiropoulou, T., Tsoumpa, M., Griva, P., Galarioti, V., and Matsota, P. (2022). Prediction and Prevention of Intraoperative Hypotension with the Hypotension Prediction Index: A Narrative Review. J. Clin. Med., 11.","DOI":"10.3390\/jcm11195551"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1214","DOI":"10.1097\/ALN.0000000000003557","article-title":"Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery","volume":"133","author":"Maheshwari","year":"2020","journal-title":"Anesthesiology"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1046\/j.1365-2044.1998.00315.x","article-title":"Reporting of \u2018hypotension\u2019 after epidural analgesia during labour. Effect of choice of arm and timing of baseline readings","volume":"53","author":"Kinsella","year":"1998","journal-title":"Anaesthesia"},{"key":"ref_15","first-page":"Cd003401","article-title":"Combined spinal-epidural versus epidural analgesia in labour","volume":"10","author":"Simmons","year":"2012","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1007\/s10488-010-0319-7","article-title":"Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda","volume":"38","author":"Proctor","year":"2011","journal-title":"Adm. Policy Ment. Health"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1186\/s13012-017-0635-3","article-title":"Psychometric assessment of three newly developed implementation outcome measures","volume":"12","author":"Weiner","year":"2017","journal-title":"Implement. Sci."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"499","DOI":"10.2307\/2531021","article-title":"Sample-size formula for the proportional-hazards regression model","volume":"39","author":"Schoenfeld","year":"1983","journal-title":"Biometrics"},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"\u0160ribar, A., Jurinjak, I.S., Almahariq, H., Bandi\u0107, I., Mato\u0161evi\u0107, J., Peji\u0107, J., and Per\u0161ec, J. (2023). Hypotension prediction index guided versus conventional goal directed therapy to reduce intraoperative hypotension during thoracic surgery: A randomized trial. BMC Anesthesiol., 23.","DOI":"10.1186\/s12871-023-02069-1"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Lorente, J.V., Ripoll\u00e9s-Melchor, J., Jim\u00e9nez, I., Becerra, A.I., Mojarro, I., Fern\u00e1ndez-Valdes-Bango, P., Fuentes, M.A., Moreno, A., Agudelo, M.E., and Villar-Pellit de la Vega, A. (2023). Intraoperative hemodynamic optimization using the hypotension prediction index vs. goal-directed hemodynamic therapy during elective major abdominal surgery: The Predict-H multicenter randomized controlled trial. Front. Anesthesiol., 2.","DOI":"10.3389\/fanes.2023.1193886"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"100297","DOI":"10.1016\/j.xagr.2023.100297","article-title":"Side effects from epidural analgesia in laboring women and risk of cesarean delivery","volume":"4","author":"Ghidini","year":"2024","journal-title":"AJOG Glob. Rep."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"564","DOI":"10.1016\/j.jgyn.2013.02.006","article-title":"Analysis of fetal heart rate abnormalities occurring within one hour after laying of epidural analgesia","volume":"42","author":"Korb","year":"2013","journal-title":"J. Gynecol. Obs. Biol. Reprod."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/14\/5037\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:10:59Z","timestamp":1760033459000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/14\/5037"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,16]]},"references-count":22,"journal-issue":{"issue":"14","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["jcm14145037"],"URL":"https:\/\/doi.org\/10.3390\/jcm14145037","relation":{},"ISSN":["2077-0383"],"issn-type":[{"type":"electronic","value":"2077-0383"}],"subject":[],"published":{"date-parts":[[2025,7,16]]}}}