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Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

4 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • UT Southwestern Medical Center - Clements University Hospital
        • Investigador principal:
          • Noah Jouett, DO, PhD
        • Contato:
        • Subinvestigador:
          • Ulrike Hoffmann, MD, PhD
        • Subinvestigador:
          • Peiman Lahsaei, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Texas Southwestern Medical Center

Investigadores

  • Investigador principal: Noah Jouett, DO, PhD, University of Texas Southwestern Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

11 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STU20260828

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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