The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery

Официальное название

The Hypotension Prediction Index Software Compared With Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery: A Prospective Randomized Controlled Trial

Обзор

The standard procedure during general anesthesia is to monitor vital functions, including cardiovascular functions such as cardiac electrical activity, using continuous ECG recording, blood pressure measurement with a sphygmomanometer, heart rate measurement, and tissue oxygenation measurement with a pulse oximeter. These are non-invasive methods, which are often insufficient in the case of extensive procedures within the abdominal aorta. In such cases, the anesthesiologist additionally use direct blood pressure measurements and central venous pressure measurements. To perform these measurements, it is necessary to insert a cannula into an artery (usually the radial artery) and a catheter into the central veins (through the internal jugular or subclavian vein). Vascular cannulation is an invasive method and may be associated with complications such as vascular thrombosis, infection at the puncture site or catheter-related infections, pneumothorax, air embolism, cardiac arrhythmias, neuropathies, hematomas, and bleeding. At the same time, they allow for a more accurate assessment of cardiovascular function and the implementation of appropriate treatment, including the administration of large amounts of infusion fluids, vasoconstrictors, and cardiac support drugs. In the current study, the investigators will additionally use a special sensor and monitor to assess the heart's performance (cardiac output) and its response to the treatment used, optimizing and supporting the circulatory system. This monitoring requires the insertion of a catheter into a central vein and artery, which is necessary during vascular surgery procedures and does not involve any additional invasive procedures. In the postoperative period, the investigators will analyze the frequency of abnormalities in laboratory tests routinely collected after surgery and the function of the central nervous system by performing simple non-invasive cognitive function tests. The benefits of using the method of assessing the patient's response to surgery and anesthesia in presented study are related to increased safety for each patient and improved perioperative treatment for all patients undergoing surgery.

Вмешательства

• Устройство HPI guided heamodynamic monitoring
  The investigators hypothesise that HPI-guided haemodynamic management, when implemented with protocol refinements to mitigate hypertensive overcorrection, will reduce the burden of intraoperative hypotension compared with standard APCO monitoring in patients undergoing major abdominal aortic surgery. Secondary objectives include evaluation of postoperative organ injury, assessment of intraoperative hypertension as a safety outcome, and characterisation of fluid and vasopressor requirements. By t
• Устройство Standard Heamodynamic Managament according to APCO Monitoring
  Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg

Первичные конечные точки

• time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP < 65 mmHg) [Срок оценки: From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]

Вторичные конечные точки (3)

• Intraoperative hypertension [Срок оценки: From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days]
• All-cause mortality at 90 days [Срок оценки: postoperative 90 days]
• Composite postoperative organ complications within 7 days [Срок оценки: 7 postoperative days]

Критерии участия

Критерии включения

• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status classification III or IV
• Scheduled for elective major abdominal aortic surgery (open or endovascular repair) with an expected surgical duration exceeding 2 hours
• Able to provide written informed consent

Критерии исключения

• Emergency or urgent surgery
• Pregnancy or breastfeeding or positive/uncertain pregnancy test
• Haemodynamically significant valvular heart disease:

• Severe aortic stenosis (aortic valve area < 1.5 cm\^2)
• Moderate to severe aortic regurgitation
• Moderate to severe mitral regurgitation
• Moderate to severe mitral stenosis
• Severe heart failure with left ventricular ejection fraction < 35%
• Permanent atrial fibrillation (reduces accuracy of pulse contour analysis)
• Inability to provide informed consent
• Participation in another interventional trial that may influence haemodynamic management or study outcomes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Польша · 1 центр

• Department of Anesthesiology and Intensive Therapy — Poznan

Публикации

• Ripolles-Melchor J, Tome-Roca JL, Zorrilla-Vaca A, Aldecoa C, Colomina MJ, Bassas-Parga E, Lorente JV, Ruiz-Escobar A, Carrasco-Sanchez L, Sadurni-Sarda M, Rivas E, Puig J, Agudelo-Montoya E, Del Rio-Fernandez S, Garcia-Lopez D, Adell-Perez AB, Guillen A, Venturoli-Ojeda R, Fernandez-Torres B, Abad-Motos A, Mojarro I, Garrido-Calmaestra JL, Fernanz-Anton J, Pedregosa-Sanz A, Cueva-Castro L, Echeva PMID 39746186
• Giustiniano E, Nisi F, Ferrod F, Lionetti G, Viscido C, Reda A, Piccioni F, Buono G, Cecconi M. Intraoperative hemodynamic management in abdominal aortic surgery guided by the Hypotension Prediction Index: the Hemas multicentric observational study. J Anesth Analg Crit Care. 2025 Feb 13;5(1):7. doi: 10.1186/s44158-024-00222-x. PMID 39948674
• Pilakouta Depaskouale MA, Archonta SA, Katsaros DM, Paidakakos NA, Dimakopoulou AN, Matsota PK. Beyond the debut: unpacking six years of Hypotension Prediction Index software in intraoperative hypotension prevention - a systematic review and meta-analysis. J Clin Monit Comput. 2024 Dec;38(6):1367-1377. doi: 10.1007/s10877-024-01202-w. Epub 2024 Jul 24. PMID 39048785
• Sun Y, Chai F, Pan C, Romeiser JL, Gan TJ. Effect of perioperative goal-directed hemodynamic therapy on postoperative recovery following major abdominal surgery-a systematic review and meta-analysis of randomized controlled trials. Crit Care. 2017 Jun 12;21(1):141. doi: 10.1186/s13054-017-1728-8. PMID 28602158
• Szrama J, Gezela M, Zuranski L, Kulas K, Gajda M, Smuszkiewicz P, Sobczynski P. Hypotension Prediction Index Software Compared with Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery: A Retrospective Study. J Clin Med. 2025 Dec 12;14(24):8791. doi: 10.3390/jcm14248791. PMID 41464693
• Ranucci M, Barile L, Ambrogi F, Pistuddi V; Surgical and Clinical Outcome Research (SCORE) Group. Discrimination and calibration properties of the hypotension probability indicator during cardiac and vascular surgery. Minerva Anestesiol. 2019 Jul;85(7):724-730. doi: 10.23736/S0375-9393.18.12620-4. Epub 2018 Nov 22. PMID 30481996
• Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300. PMID 29894315
• Giglio M, Dalfino L, Puntillo F, Rubino G, Marucci M, Brienza N. Haemodynamic goal-directed therapy in cardiac and vascular surgery. A systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2012 Nov;15(5):878-87. doi: 10.1093/icvts/ivs323. Epub 2012 Jul 24. PMID 22833509

Идентификаторы

NCT: NCT07510451 · 808/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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