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Postoperative Delirium: Brain Vulnerability and Recovery

23 mei 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Diagnostisch
Toewijzing: Niet-gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Ander: 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.	Apparaat: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients Apparaat: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients Apparaat: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients
Ander: no delirium Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm	Apparaat: EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients Apparaat: fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients Apparaat: fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. Andere namen: brain monitoring in delirious postoperative patients

Deelnemersgroep / Arm

Interventie / Behandeling

Ander: 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.

Apparaat: EEG