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Postoperative Delirium: Brain Vulnerability and Recovery

23 maggio 2020 aggiornato da: Ben Palanca, Washington University School of Medicine

In this study, we propose to use EEG and a brain imaging technique known as diffuse optical tomography (DOT) to study when people are in delirium and when they recovery. We plan to also compare brain function of patients who recovered from delirium to patients who did not have delirium using DOT and fMRI. We will also continually monitor the participant's EMR to help coordinate timing of study procedures, as well as to collect information pertaining to their surgery, recovery progress, and indicators of mental status including delirium.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is a potentially life-threatening condition. As many as half of patients that have heart and non heart-related surgery will experience postoperative delirium. Patients diagnosed with postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is an under-diagnosed condition with a variable delay in when it appears. Additionally, there are no objective tools or tests that can be before or after surgery to anticipate and identify those patients who are at risk. Electroencephalography [EEG] and functional magnetic resonance imaging [fMRI] have helped us understand the changes in the brain during delirium. These suggest that a weakening in correlated activity within a group of brain regions, known as the default mode network (DMN), may be related to delirium.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Non applicabile

Contatti e Sedi

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

Luoghi di studio

Stati Uniti
- Missouri
  - Saint Louis, Missouri, Stati Uniti, 63110
    - Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

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

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Common inclusion criteria:

Age ≥ 60
Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
English speaking.

Common exclusion criteria:

Implanted pacemaker
Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated
Concomitant aortic or cerebrovascular procedure
Inability to lay flat or still for MRI
Legal blindness or severe deafness
Seizure history
Known focal brain lesion larger than 3 cm.

Delirium Case Arm:

1. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5.

Postoperative Control Arm:

1. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.

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

Scopo principale: Diagnostico
Assegnazione: Non randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Altro: delirium Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.	Dispositivo: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients Dispositivo: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients Dispositivo: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients
Altro: no delirium Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm	Dispositivo: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients Dispositivo: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients Dispositivo: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Altri nomi: brain monitoring in delirious postoperative patients

Gruppo di partecipanti / Arm

Intervento / Trattamento

Altro: delirium

Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.

Dispositivo: EEG