AUTOREGULATE- NONCARDIAC-COTRENDING
Feasibility and Clinical Implications of Real-time Cerebral Autoregulation Monitoring in Major Noncardiac Surgery With the Medtronic Cotrending Algorithm (AUTOREGULATE- NONCARDIAC-COTRENDING)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Basel、スイス、4031
- Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Technical feasibility of using the Medtronic Cotrending algorithm
時間枠：one time assessment at study end
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Specifically, it will be determined:
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one time assessment at study end
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
時間枠：one time assessment at study end
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Determination of the extent of between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.
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one time assessment at study end
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Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
時間枠：one time assessment at study end
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Determination of the extent of within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation.
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one time assessment at study end
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Predictability of intraoperative Cotrending-derived boundaries of cerebral autoregulation
時間枠：one time assessment at study end
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Determination to what extent the intraoperative Cotrending-derived boundaries of cerebral autoregulation can be predicted using preoperative or preinduction blood pressures.
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one time assessment at study end
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Within-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
時間枠：one time assessment at study end
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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.
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one time assessment at study end
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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
時間枠：one time assessment at study end
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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.
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one time assessment at study end
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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
時間枠：one time assessment at study end
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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.
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one time assessment at study end
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協力者と研究者
捜査官
- 主任研究者：Patrick M. Wanner、Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-02371; am26Wanner
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医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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