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Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • UT Southwestern Medical Center - Clements University Hospital
        • Investigatore principale:
          • Noah Jouett, DO, PhD
        • Contatto:
        • Sub-investigatore:
          • Ulrike Hoffmann, MD, PhD
        • Sub-investigatore:
          • Peiman Lahsaei, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Texas Southwestern Medical Center

Investigatori

  • Investigatore principale: Noah Jouett, DO, PhD, University of Texas Southwestern Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

18 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STU20260828

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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