跳至主要内容
临床试验/NCT06202638
NCT06202638招募中不适用

An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.

John Paul II Hospital, Krakow3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
3
主要终点
Positive predictive value

研究概览

简要总结

Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.

详细描述

The Hypotension Prediction Index (HPI) is a hemodynamic score designed specifically for prediction of the intraoperative hypotension (IOH) episodes. It is based on an algorithm programmed into Edwards Lifesciences HemoSphere monitor clinical platform (Irvine, CA, USA). The HPI is based on a continuous analysis of an arterial pressure waveform. It is processed in addition to the FloTrac algorithm via proprietary Acumen IQ Sensor and uses an artificial intelligence technology. After internal validation, the algorithm was prospectively, externally and clinically validated in general surgical, perioperative patients, cardiovascular surgical patients, and mechanically ventilated COVID-19 ICU patients.

As opposed to conventional monitoring systems, which display physiological parameters in real life, an HPI algorithm detects the earliest changes, multivariate variability and interactions in the physiologic inter-related data on preload, afterload, and contractility to deliver an index predicting an upcoming hypotensive event. Variables used by the patent-protected algorithm to calculate HPI are as follows: heart rate variability (changes in heart rate/changes in MAP); arterial pressure waveform complexity (approximate waveform entropy, sample waveform entropy, frequency domain measure of higher order harmonics); preload parameters (pulse pressure variation PPV, stroke volume variation SVV); contractility parameters (slope of the ascending part of the pressure waveform above time, dP/dt); and afterload parameters (SVR, dynamic arterial elastance Eadyn), but their relative contribution to final index is not revealed.

Final index values of HPI range from 1 to 100, with increasing numbers representing a greater likelihood of an impending hypotensive event. These events are defined as mean arterial pressure (MAP) <65 mmHg occurring for over one minute. HPI values predict the occurrence of hypotension five to fifteen minutes before the event, with sensitivity and specificity in both time-frames of greater than 80%. In most studies, a value of 85 HPI predicts a hypotensive episode, and this value is arbitrarily preprogrammed into the HemoSphere monitor to alert the clinician and allow proactive responses to minimize or even entirely prevent intraoperative hypotension.

Parameters used and incorporated into the HemoSphere monitor can guide a clinician in the optimal management of IOH. These "secondary screen" variables include the left ventricular contractility parameter (dP/dt), dynamic preload parameter (SVV) and afterload parameter dynamic arterial elastance Eadyn.

Maximal left ventricular (LV) pressure rise (LV dP/dt max) is a classical marker of LV performance and systolic function. It is conventionally defined as the change in pressure in the left ventricular cavity over the isovolumetric contraction period and it originally requires LV catheterization. In clinical practice a surrogate peripheral arterial pressure waveform is used to estimate dP/dt value and to predict the need for inotropic support.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status II to IV;
  • Planned invasive blood pressure monitoring during general anesthesia expected to last more than 2 hours and planned overnight hospitalization.
  • Procedures: video-assist thoracoscopic (VATS)-lobectomy, open-thoracotomy lobectomy, pneumonectomy.
  • Adults over 18 years old.

排除标准

  • Urgent/emergency procedures.
  • Patients with known clinically important intracardiac shunts.
  • Moderate to severe valvular disease.
  • Preoperative symptomatic arrhythmias including AF.
  • Congestive heart failure with LV ejection fraction less than 35%.
  • Refusal of participation

结局指标

主要结局

Positive predictive value

时间窗: Intraoperative period

* Positive predictive value (precision) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients * Sensitivity (recall) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients. * Calibration curve (incidence of IOH vs. HPI; 95% CI)

次要结局

  • Event rate(Intraoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirosław Ziętkiewicz

Principal Investigator; Head of the Anesthesia and Intensive Care Unit

John Paul II Hospital, Krakow

研究点 (3)

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