Clinical trial · Interventional
Influence of the "Hypotension Probability Index" on Intraoperative and Postoperative Hypotension in ENT- and OM-Surgery
Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative and Postoperative Hypotension During Extended Surgical Procedures in ENT- and OM-Surgery
NCT04151264CI-TRIAL-00087844completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Anesthesia | — | UNRESOLVED | — |
| ENT Disease | — | UNRESOLVED | — |
| Hypotension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypotension probability index (HPI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- blinded HPI monitoring
- type
- ACTIVE_COMPARATOR
- label
- Intervention Arm
- description
- HPI monitoring to predict hypotension
- interventionNames
- Device: Hypotension probability index (HPI)
Primary outcomes (1)
- measure
- number (n) of intraoperative and postoperative hypotension
- timeFrame
- until 4 hours after the end of surgery
- description
- MAP below 65 mmHg for more than one minute in ventilated patients
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * extensive surgery in the head and neck area * Age ≥ 18 years Exclusion Criteria: * Participation in another interventional study * Pregnancy and nursing mothers * Surgery without controlled ventilation * Contraindication to invasive arterial pressure measurement * Renal insufficiency KDIGO stage ≥ 3 * Congenital coagulation disorder
References
Publications (4)
- BACKGROUNDBijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930. PMID 19934864
- BACKGROUNDMonk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E. PMID 15616043
- BACKGROUNDBijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320. PMID 22277949
- DERIVEDAli Akbari A, Koch C, Schmidt G, Schmermund D, Langer C, Edinger F, Denn SM, Markmann M, Sander M, Habicher M. Artificial intelligence-based predictive hemodynamic monitoring in conjunction with goal-directed therapy reduces duration, frequency, and severity of intraoperative hypotension in major maxillofacial and otolaryngological surgery-a prospective randomized controlled pilot trial. J Anesth Analg Crit Care. 2025 Dec 22;5(1):92. doi: 10.1186/s44158-025-00331-1. PMID 41423680