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临床试验/NCT04149314
NCT04149314已完成不适用

PGDT With the "Hypotension Prediction Index" to Reduce the Number and Duration of Intraoperative Hypotension and the Incidence of Renal Failure in Patients Undergoing Lung Surgery

University of Giessen2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
2
主要终点
Incidence of intraoperative hypotension

研究概览

简要总结

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort.

The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

详细描述

Monitoring of blood pressure is a basic tool to assess the patients' hemodynamic status. Physiological blood pressure is usually close to 120/80 mmHg. Hypotension is not clearly defined as shown in previous studies 1, 20, 21. Some studies defined hypotension as a systolic blood pressure below 100 mmHg or a mean arterial pressure below 60 mmHg 1,2. Depending on the definition intraoperative hypotension (IOH) hypotension can occur in 38% of patients undergoing non-cardiac surgery. 53% of these patients die within one year. Monk et al. noted that the 1-year-mortality was raised by 3.6% for every minute the systolic blood pressure was below 80 mmHg. The risk of mortality was raised up to 1.4 times when the MAP was under 55 mmHg for more than 10 minutes 3. Additionally, in 2015 it was shown that even short duration of MAP under 55 mmHg is associated with a high risk for acute kidney injury and myocardial infarction 4. A recent definition of hypotension was published by of Vernooij et al. that defined IOH as a decrease of MAP < 65 mmHg for more than one minute in this study 22. Perioperative hypotension is a complication that can occur in the induction period and in the following phase. Recent unpublished data from the Sessler group presented at the 2018 ASA meeting in San Francisco showed that about 1/3 of hypotensive episodes are unrelated to surgery as those occur before the surgeon is in the OR 28. The reasons for hypotension can be found in vasodilatation (e. g. drug induced), volume deficit (based on blood loss), or negative inotropic effect of surgery and anesthetic drugs (reduced left ventricular function). Main factors causing intraoperative hypotension according to literature are age, preexisting diseases (especially ASA > 3), duration of surgery, acuteness of surgery (emergency), anti-hypertensive medication and anesthesia combining general and regional anesthesia 5,6. Complications related to hypotension can be detected in most organ systems. One important source of hypotension-associated complications are cardiovascular complications. Recently, a syndrome that was termed myocardial injury after non-cardiac surgery (MINS) was shown to be associated with hypotension and lead to increased postoperative mortality rate 23, 24. Acute kidney injury (AKI) affects up to 25% of patients in the intensive care unit 7. Liu et al. described that an episode of relative hypotension is often followed by AKI (a decrease in systolic blood pressure relative to pre-morbid value was a significant independent predictor of the development of AKI and of RIFLE classes I and F; odds ratio 1.084 for every -1 mmHg change in systolic blood pressure) 8. As stated, 'normotensive renal failure' is not common and a rare phenomenon in the absence of septic and other complications. This results are supported by other publications, like Lehmann et al. 9. Their results indicate that the risk of AKI was related to the severity of hypotension with an odds ratio (OR) of 1.03, 95% CI 1.02-1.04 (p < 0.0001) per 1 mmHg decrease in minimum MAP ≥ 80 mmHg. For each additional hour MAP was less than 70, 60, 50 mmHg, the risk of AKI increased by 2% (OR 1.02, 95% CI 1.00-1.03, p = 0.0034), 5% (OR 1.05, 95% CI 1.02-1.08, p = 0.0028), and 22% (OR 1.22, 95% CI 1.04-1.43, p = 0.0122).

Renal failure poses a relevant complication in the perioperative phase 5, 6. Over the last decade the cell cycle arrest biomarkers TIMP-2- and IGFBP7-quantification (Nephrocheck) has been successfully evaluated for the detection of AKI 7. The main advantage of both parameters is the opportunity of early detection of AKI and its point-of-care design, which makes them especially for the use on the intensive care unit valuable. Based on these facts, the predictive measurement of blood pressure is of great interest for the anesthesiologist to optimize patients' postoperative outcome.

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort.

The development of modern lung surgery started in the 19th century. Especially in Germany Rudolf Nissen (first pneumonectomy, 1931) and Ferdinand Sauerbruch were the first pioneers of lung surgery. With enhancement and refinement of thoracic anesthesiology (lung separation) and further specialization of surgery, thoracic surgery became a seperate discipline. During thoracic surgery lung separation and isolation with accomplished single-lung ventilation plays a key role in the development of thoracic surgery. Spectrum of indication contains thoracic surgery, procedure- and patient-dependent factors. Usually lung isolation is achieved with a double-lumen tube or a bronchial blocker. Major domain of thoracic surgery is nowadays oncological surgery of lung cancer. With modern imaging lung cancer is detected in early stage, so more operations can be performed. Additional in the last thirty years more and more minimal invasive procedures (VATS) were performed which result in gentle and successful treatment of thoracic surgical patients.

Beside oncological surgeries (which make almost 50% of all procedures in thoracic surgery) plays surgery of inflammable diseases and pulmonary emphysema a major role.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

In the interventional study group HPI monitoring is used for hemodynamic optimization while in the control group HPI monitoring is blinded.

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

  • Patients undergoing lung surgery with one-lung-ventilation
  • General anesthesia
  • Age ≥ 18 years

排除标准

  • Participation in another (interventional) study
  • Pregnancy and nursing mothers
  • Surgery without controlled ventilation
  • ASA I or IV
  • Contraindication for invasive blood pressure monitoring
  • Coagulation disorder
  • Arterial Fibrillation

结局指标

主要结局

Incidence of intraoperative hypotension

时间窗: up to 8 hours

Frequency (n) and duration (t \[min\]) of intraoperative hypotension, defined as MAP below 65mmHg for one minute.

次要结局

  • Hospital stay(From admission to hospital until discharge of hospital up to 18 month)
  • Renal failure(preoperative, immediately after operation and day 1 after operation)
  • Concentration of troponin(preoperative, immediately after operation and day 1 after operation)
  • Hemodynamic status(up to 8 hours)
  • Procedual Data(until the end of anesthesia)
  • POMS (Postoperative Morbidity Survey Score)(day 1, 3 and 5 after operation)
  • Circulation supportive mediaction(from beginning until the end of surgery)
  • Mortality after surgery(up to 180 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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