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Postoperative Delirium: Brain Vulnerability and Recovery

23. května 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Diagnostický
Přidělení: Nerandomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Jiný: 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.	Přístroj: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients Přístroj: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients Přístroj: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients
Jiný: no delirium Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm	Přístroj: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients Přístroj: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients Přístroj: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Ostatní jména: brain monitoring in delirious postoperative patients

Skupina účastníků / Arm

Intervence / Léčba

Jiný: 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.

Přístroj: EEG