Clinical trial · Observational
Perioperative Hypotension in Gynaecologic Oncologic Surgery: HPI-ClearSight Versus Arterial Waveform Analysis
Non-Invasive Hemodynamic Monitoring and Incidence of Perioperative Hypotension in Gynaecologic Oncologic Surgery: Hypotension Prediction Index Working With ClearSight Versus Arterial Waveform Analysis Alone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background Intraoperative hypotension is associated with increased morbidity and mortality. The Hypotension Prediction Index (HPI) is an advancement of the arterial waveform analysis to predict intraoperative hypotension minutes before episodes occur enabling preventive treatments. This study will test the hypothesis that a hemodynamic treatment protocol based on HPI working with non-invasive ClearSight system reduces intraoperative hypotension when compared to standard goal directed therapy (GDT) in patients undergoing gynaecologic oncologic surgery. Methods A retrospective analysis of 68 adult consecutive patients undergoing gynaecologic oncologic surgery with non-invasive arterial pressure monitoring using either index guidance (HPI) or classic ClearSight system waveform analysis depending on availability (ClearSight, n = 36; HPI, n = 32) will be conducted. A hemodynamic GDT protocol was applied in both groups. The primary endpoint will be the incidence and duration of hypotensive events defined as MAP \<65 mmHg evaluated by time-weighted average of hypotension.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Hemodynamic Instability | — | UNRESOLVED | — |
| Hypotension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypotension Prediction Index | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hypotension Prediction Index (HPI) group
- description
- Hemodinamic monitoring with HPI working with ClearSight
- interventionNames
- Device: Hypotension Prediction Index
- label
- Control group
- description
- Hemodinamic monitoring with classic ClearSight
Primary outcomes (1)
- measure
- Cumulative Intraoperative Hypotension
- timeFrame
- At the end of surgery
- description
- Comparison, in the two groups, of the amount of intraoperative hypotension (MAP \< 65 mmHg), measured with TWAMAP method.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Gynecologic Oncologic surgery procedures Exclusion Criteria: * Severe valvulopathy * Cardiac failure * Severe aortic stenosis * Severe cardiac arrhythmias * Coagulopathy * Contraindication to arterial calculation * Patient's refusal
References
Publications (28)
- RESULTBijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, 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 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e. PMID 17667564
- RESULTVernooij 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 May;120(5):1080-1089. doi: 10.1016/j.bja.2018.01.033. Epub 2018 Mar 21. PMID 29661385
- RESULTAn R, Pang QY, Liu HL. Association of intra-operative hypotension with acute kidney injury, myocardial injury and mortality in non-cardiac surgery: A meta-analysis. Int J Clin Pract. 2019 Oct;73(10):e13394. doi: 10.1111/ijcp.13394. Epub 2019 Sep 11. PMID 31332896
- RESULTSalmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. 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 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432. PMID 27792044
- RESULTWesselink 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 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20. PMID 30236233
- RESULTScholz AF, 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 Jan;103(2):e21-8. doi: 10.1002/bjs.10062. Epub 2015 Dec 16. PMID 26676760