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Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

4 maja 2026 zaktualizowane przez: Noah Jouett, University of Texas Southwestern Medical Center

Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery: A Single-Center Cohort Study of Quantitative EEG, Noninvasive Intracranial Dynamics, and Perioperative Physiologic Correlates

This is a prospective observational cohort study of adult patients undergoing high-risk surgery at UT Southwestern Medical Center. The study acquires synchronized multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) extracted from standard-of-care clinical monitoring and, where deployed, Brain4Care (B4C) noninvasive intracranial dynamics data - and links these data to perioperative hemodynamic, medication, laboratory, procedural, and outcome variables. No alteration of routine clinical care occurs. The primary goal is to characterize associations between monitor-derived features and perioperative clinical variables, and to establish a multimodal dataset supporting future analyses of perioperative brain health in high-risk surgical populations.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

BACKGROUND: Patients undergoing major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, and neurosurgical craniotomy are exposed to substantial perioperative physiologic stress, including hemodynamic instability, blood loss, cardiopulmonary bypass, and procedure-specific periods of altered cerebral perfusion. Quantitative electroencephalography and noninvasive assessments of intracranial dynamics may provide complementary information about brain state and cerebrovascular physiology during these high-risk operations. However, the relationships between monitor-derived features and intraoperative events - including hypotension, anesthetic transitions, major surgical events, and postoperative outcomes - remain incompletely characterized.

DESIGN: Single-center prospective observational cohort study at UT Southwestern Medical Center. SedLine quantitative EEG data are extracted from standard-of-care clinical monitoring for all enrolled subjects. Brain4Care (B4C) noninvasive intracranial dynamics monitoring may additionally be placed as a research device depending on study workflow, patient characteristics, technical feasibility, and clinical context. Either monitoring configuration - SedLine alone or SedLine combined with B4C - constitutes a complete and valid study encounter.

The Moberg Clinical Platform (Moberg Analytics; FDA-cleared multimodal data integration system) serves as the primary data acquisition hub where deployed in the operating room, aggregating synchronized high-resolution physiologic waveforms alongside SedLine and B4C outputs. Where Moberg is unavailable, hemodynamic and physiologic variables are collected retrospectively from the Epic intraoperative anesthesia record.

MONITORING MODALITIES:

Research device placed specifically for this study (where deployed):

- Brain4Care (B4C) extensometry: skull-mounted noninvasive sensor recording cranial compliance-related waveform morphology (P2/P1 ratio, Time to Peak).

Standard-of-care clinical data recorded for research purposes:

  • SedLine (Masimo): 4-channel frontal quantitative EEG providing Patient State Index, Spectral Edge Frequency, and exportable raw EDF-format waveforms.
  • Moberg Clinical Platform: multimodal physiologic waveform integration including arterial blood pressure, SpO2, ECG, ventilator-derived parameters, temperature, and EtCO2.

DATA MANAGEMENT: Subjects are assigned unique study identifiers. Direct identifiers are removed from analytic datasets. Research data are stored on secure, institutionally approved systems accessible only to IRB-authorized study personnel. De-identified data may be shared with qualified external collaborators under executed data use agreements.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75390
        • UT Southwestern Medical Center - Clements University Hospital
        • Główny śledczy:
          • Noah Jouett, DO, PhD
        • Kontakt:
        • Pod-śledczy:
          • Ulrike Hoffmann, MD, PhD
        • Pod-śledczy:
          • Peiman Lahsaei, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Adult patients age 18 years or older scheduled to undergo major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, or neurosurgical craniotomy at UT Southwestern Medical Center. These populations were selected because they commonly experience substantial perioperative hemodynamic and physiologic perturbations.

Opis

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled to undergo major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, or neurosurgical craniotomy at UT Southwestern Medical Center
  • Able to provide informed consent (self or legally authorized representative when applicable)
  • Safe and feasible placement of SedLine and/or Brain4Care monitoring as determined by the clinical and research teams
  • Anticipated availability of perioperative clinical data needed for study analyses

Exclusion Criteria:

  • Age younger than 18 years
  • Prisoner status
  • Pregnancy
  • Unable to provide informed consent in English (consent documents available in English only)
  • Declining participation
  • Lack of subject or legally authorized representative consent when required
  • Clinical condition preventing safe or feasible placement of study monitors (e.g., incompatible surgical field location, significant facial or scalp injury, open wounds at intended sensor placement site)
  • Operative workflow or clinical urgency precluding reasonable completion of consent and monitor placement prior to start of surgery
  • Anticipated clinical data capture insufficient for meaningful analysis

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
High-Risk Surgical Patients
Adult patients age 18 years or older undergoing major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, or neurosurgical craniotomy at UT Southwestern Medical Center. All participants undergo SedLine qEEG data capture from existing standard-of-care clinical monitoring. A subset additionally undergo B4C noninvasive intracranial dynamics monitoring as a research device.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Ramy czasowe: Intraoperative period (duration of surgery, typically 2-12 hours)
Percentage of total enrolled cases yielding analyzable SedLine Patient State Index (PSI) epochs during the intraoperative period. Signal quality assessed by artifact burden and data completeness. Reported as a single proportion (percentage of cases with analyzable PSI data) across surgical case types.
Intraoperative period (duration of surgery, typically 2-12 hours)
Proportion of enrolled cases with analyzable Brain4Care extensometry (P2/P1 ratio) recording during surgery
Ramy czasowe: Intraoperative period (duration of surgery, typically 2-12 hours)
Percentage of total enrolled cases yielding analyzable Brain4Care (B4C) extensometry P2/P1 ratio epochs during the intraoperative period. Signal quality assessed by artifact burden and adequate waveform morphology. Reported as a single proportion (percentage of cases with analyzable B4C data) across surgical case types.
Intraoperative period (duration of surgery, typically 2-12 hours)
Correlation between SedLine Patient State Index and intraoperative mean arterial pressure
Ramy czasowe: Intraoperative period through 90 days post-surgery
Spearman correlation coefficient between SedLine-derived Patient State Index (PSI) values and concurrently recorded intraoperative mean arterial pressure. Secondary within-case correlation analyses with vasoactive drug administration epochs, anesthetic transitions, blood loss events, and major surgical epochs will also be reported as correlation coefficients.
Intraoperative period through 90 days post-surgery
Correlation between Brain4Care extensometry P2/P1 ratio and intraoperative mean arterial pressure
Ramy czasowe: Intraoperative period through 90 days post-surgery
Spearman correlation coefficient between Brain4Care (B4C) extensometry-derived P2/P1 ratio values and concurrently recorded intraoperative mean arterial pressure. Secondary within-case correlation analyses with vasoactive drug administration epochs, anesthetic transitions, blood loss events, and major surgical epochs will also be reported as correlation coefficients.
Intraoperative period through 90 days post-surgery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Ramy czasowe: In-hospital postoperative period (expected 2-14 days post-surgery)
Rate of postoperative delirium as documented by Confusion Assessment Method (CAM) assessments in nursing records during the postoperative hospital stay, reported as incidence (percentage of enrolled patients with at least one positive CAM screen). Secondary analyses will examine associations between intraoperative SedLine PSI or B4C P2/P1 ratio features and postoperative delirium occurrence.
In-hospital postoperative period (expected 2-14 days post-surgery)
Proportion of cases with computable cerebrovascular reactivity indices from Brain4Care extensometry and arterial blood pressure data
Ramy czasowe: Intraoperative period
Percentage of enrolled cases in which cerebrovascular reactivity-related indices can be computed from acquired Brain4Care (B4C) extensometry waveforms and concurrent arterial blood pressure data, reported as a single proportion with characterization of index distributions across surgical populations.
Intraoperative period
Functional status at 90 days post-surgery assessed by modified Rankin Scale via medical record review
Ramy czasowe: 90 days post-surgery
Functional and neurological status assessed by modified Rankin Scale (mRS) score via medical record review and/or structured contact at up to 90 days from date of surgery. Reported as ordinal mRS score (0-6).
90 days post-surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Texas Southwestern Medical Center

Śledczy

  • Główny śledczy: Noah Jouett, DO, PhD, University of Texas Southwestern Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

18 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 maja 2026

Pierwszy wysłany (Rzeczywisty)

11 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STU20260828

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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