Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia

Официальное название

The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia.

Обзор

This study investigates if the Hypotension Prediction Index (HPI) combined with the Assisted Fluid Management (AFM) software can improve perioperative hemodynamic management in adult patients undergoing general anesthesia. The main question is : Does the HPI and AFM software reduce the incidence and duration of intraoperative hypotension? Does the HPI and AFM software optimize fluid and vasopressor administration? Does the HPI and AFM software improve perioperative outcomes? Participants will be randomly allocated to either an experimental group receiving goal directed hemodynamic therapy guided by HPI and AFM or a control group receiving conventional hemodynamic management.

Подробное описание

Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes.

The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early.

The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output.

This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia.

A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg.

Patients in the intervention group will undergo goal directed hemodynamic management guided by HPI and AFM algorithms via the Hemosphere monitor and Acumen IQ sensor. The AFM software will determine the timing of fluid administration. Elevated HPI values indicating impending hypotension will be managed in a targeted manner with fluids, vasopressors or inotropes.

Patients in the control group will receive conventional hemodynamic management , based on clinical judgement, in accordance with international guidelines. Although an Acumen IQ sensor will be placed, HPI and AFM indications will not be visible to the attending anesthesiologist and will not influence clinical decision making.

Intraoperative hemodynamic data will be continuously recorded in both groups. A member of the research team will be present to supervise the procedure. The primary outcome is the time-weighted average of hypotension, defined as MAP below 65 mm Hg for at least one minute. Secondary outcomes include the incidence and duration of hypotension, type and dose of administered therapies and protocol adherence.

Вмешательства

• Устройство Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software
  The Acumen IQ sensor will be used with the Hemosphere monitor to guide goal-directed hemodynamic therapy. HPI predicts impending hypotension and AFM guides fluid administration. Clinicians will follow a protocol algorithm to prevent or treat intraoperative hypotension with fluids, vasopressors or inotropes.
• Другое Conventional Intraoperative Hemodynamic management
  Participants receive hemodynamic management based on the anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed , but HPI and AFM outputs are not visible to the clinician.

Первичные конечные точки

• Time-weighted average of intraoperative hypotension [Срок оценки: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation]

Вторичные конечные точки (5)

• Incidence of hypotension [Срок оценки: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation]
• Time spent in hypotension [Срок оценки: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation]
• Choice of therapy (fluids/medications) [Срок оценки: Intraoperatively, starting 10 minutes after anesthesia induction or start of sedation]
• Dose of therapy (fluids/medications) [Срок оценки: Intraoperatively, starting 15 minutes after anesthesia induction.]
• Protocol deviations [Срок оценки: Intraoperatively, starting 15 minutes after anesthesia induction]

Критерии участия

Критерии включения

• Age > 18 years
• Intraoperative monitoring > 2 hours or general anesthesia > 2 hours
• Invasive arterial pressure monitoring
• Target MAP ≥ 65 mm Hg intraoperatively
• Written informed consent preoperatively
• ASA Physical Status ≤ 4

Критерии исключения

• Target MAP other than 65 mm Hg
• Severe preoperative hypotension (MAP < 65 mm Hg)
• Severe heart failure (e.g. LVEF < 20%)
• Emergency surgery

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

Открытое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• 2nd University Department of Anesthesiology, Attikon University Hospital — Athens

Публикации

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• Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27. PMID 27683581
• Coeckelenbergh S, Soucy-Proulx M, Van der Linden P, Roullet S, Moussa M, Kato H, Toubal L, Naili S, Rinehart J, Grogan T, Cannesson M, Duranteau J, Joosten A. Restrictive versus Decision Support Guided Fluid Therapy during Major Hepatic Resection Surgery: A Randomized Controlled Trial. Anesthesiology. 2024 Nov 1;141(5):881-890. doi: 10.1097/ALN.0000000000005175. PMID 39052844
• Coeckelenbergh S, Entzeroth M, Van der Linden P, Flick M, Soucy-Proulx M, Alexander B, Rinehart J, Grogan T, Cannesson M, Vincent JL, Vicaut E, Duranteau J, Joosten A. Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097. PMID 39116013
• Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827. PMID 29750699
• Joosten A, Alexander B, Delaporte A, Lilot M, Rinehart J, Cannesson M. Perioperative goal directed therapy using automated closed-loop fluid management: the future? Anaesthesiol Intensive Ther. 2015;47(5):517-23. doi: 10.5603/AIT.a2015.0069. Epub 2015 Nov 18. PMID 26578397
• Maheshwari K, Malhotra G, Bao X, Lahsaei P, Hand WR, Fleming NW, Ramsingh D, Treggiari MM, Sessler DI, Miller TE; Assisted Fluid Management Study Team. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Anesthesiology. 2021 Aug 1;135(2):273-283. doi: 10.1097/ALN.0000000000003790. PMID 33901281

Идентификаторы

NCT: NCT07301307 · 641/24-09-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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