Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium
Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
- Patients who can speak, read and understand the English language.
- Patients who understand the nature of the study and are willing to sign the consent form
Exclusion Criteria:
- Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
- Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
- MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
- Patients with an implant in the brain underneath the CerOx probes
- Women who are pregnant.
- History of significant, prohibitive skin allergies or reactions-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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no intervention
Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery.
Deemed interventional by JHUIRB but no actual intervention done to subject.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
Délai: 3 days post op
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To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
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3 days post op
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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recovery pattern of rSO2
Délai: 3 post op days
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To evaluate the recovery pattern of rSO2 and CBF for up to 6 hrs after CPB for ICU patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
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3 post op days
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Can CBF autoregulation can be monitored using ultrasound compared with TCD
Délai: 3 days post op
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To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD
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3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
Délai: 3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
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3 days post op
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kaushik Mandal, MD, Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NA_0007115
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