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AUTOREGULATE- NONCARDIAC-COTRENDING

2026年6月1日 更新者：University Hospital, Basel, Switzerland

Feasibility and Clinical Implications of Real-time Cerebral Autoregulation Monitoring in Major Noncardiac Surgery With the Medtronic Cotrending Algorithm (AUTOREGULATE- NONCARDIAC-COTRENDING)

This study is to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Intraoperative hypotension during noncardiac surgery is strongly associated with postoperative organ injury. The AUTOREGULATE-NONCARDIAC study, a multicenter prospective cohort study and precision medicine platform is aiming to investigate the feasibility and clinical implications of different approaches of cerebral autoregulation (cAR) monitoring in high-risk patients undergoing major noncardiac surgery (ClinicalTrials.gov NCT05336864). A central shortcoming of the currently used gold standard methodology of cerebral autoregulation monitoring (COx [Cerebral Oximetry Index] methodology) is its necessity for extended periods of monitoring data with sufficient variability, its high failure rate in certain settings, e.g. in noncardiac surgery, and the requirement for expertise in evaluating the generated cerebral autoregulatory curves.

There is a need for novel approaches to cerebral autoregulation monitoring addressing the performance and usability issues of the COx methodology. One potentially promising algorithm is the Medtronic Cotrending algorithm, which in cardiac surgery has shown strong agreement with the COx methodology and provided rapid estimates of cAR state with high uptime and user-friendly visualization of autoregulatory status. However, the Medtronic Cotrending algorithm has never been tested in noncardiac surgery.

This substudy of AUTOREGULATE-NONCARDIAC aims to prospectively assess the feasibility and clinical implications of intraoperative real-time cAR monitoring using the Medtronic Cotrending algorithm.

研究类型

观察性的

注册 (实际的)

256

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 瑞士
      • Basel、瑞士、4031
        • Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The substudy data originate from AUTOREGULATE-NONCARDIAC (NCT05336864) and will encompass all patients monitored intraoperatively with the Medtronic INVOS(TM) NIRS device, i.e. all patients included at the University Hospital Basel study center. The substudy population demographics are representative of the AUTOREGULATE-NONCARDIAC study population.

描述

Inclusion Criteria:

  • All patients included in AUTOREGULATE-NONCARDIAC at the University Hospital Basel study center with the Medtronic INVOS(TM) near-infrared spectroscopy (NIRS) device.

Exclusion Criteria:

  • No intraoperative data collected

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Technical feasibility of using the Medtronic Cotrending algorithm
大体时间：one time assessment at study end

Specifically, it will be determined:

  • Success rate of cerebral lower limit of autoregulation (cLLA) determination: proportion of patients in study cohort in whom cerebral autoregulatory parameters could be determined
  • Intraoperative uptime: percentage of intraoperative time during which presumed valid and actionable estimates of cerebral autoregulatory parameters were delivered
  • Time to first estimate of cerebral autoregulatory parameters: Elapsed intraoperative time to first presumed valid estimates of cerebral autoregulatory parameters
  • Sensitivity to external factors: Sensitivity of the algorithm to known confounders and determinants of cerebral autoregulatory function, e.g. changes in gas exchange, administration of vasopressors, skin pigmentation.
  • Sensitivity to data artefacts: Sensitivity of the algorithm to artefacts in data (e.g. in BP or rSO2 signals).
one time assessment at study end

其他结果措施

结果测量
措施说明
大体时间
Between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
大体时间：one time assessment at study end
Determination of the extent of between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.
one time assessment at study end
Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
大体时间：one time assessment at study end
Determination of the extent of within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.
one time assessment at study end
Predictability of intraoperative Cotrending-derived boundaries of cerebral autoregulation
大体时间：one time assessment at study end
Determination to what extent the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be predicted using preoperative or preinduction blood pressures.
one time assessment at study end
Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
大体时间：one time assessment at study end
Determination to what extent within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be explained by other intraoperative factors, e.g. CO2 variability.
one time assessment at study end
Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3
大体时间：one time assessment at study end
Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of postoperative organ injury (myocardial injury and/or acute kidney injury) on postoperative days 1-3.
one time assessment at study end
Association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery
大体时间：one time assessment at study end
Investigation of the association of disturbed intraoperative Cotrending-derived cerebral autoregulatory function with the composite of major cardiovascular, renal and neurological complications up to 1 year following surgery.
one time assessment at study end

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Basel, Switzerland

调查人员

  • 首席研究员：Patrick M. Wanner、Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月17日

初级完成 (实际的)

2026年1月29日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-02371; am26Wanner

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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