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AUTOREGULATE- NONCARDIAC-COTRENDING

1 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

256

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Technical feasibility of using the Medtronic Cotrending algorithm
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Between-patient variability in the intraoperative Cotrending-derived boundaries of cerebral autoregulation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Basel, Switzerland

Utredare

  • Huvudutredare: Patrick M. Wanner, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 december 2025

Primärt slutförande (Faktisk)

29 januari 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2025-02371; am26Wanner

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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