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)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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-
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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recovery pattern of rSO2
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Can CBF autoregulation can be monitored using ultrasound compared with TCD
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kaushik Mandal, MD, Johns Hopkins University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NA_0007115
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