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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02084394
Enrollment
110
Registered
2014-03-12
Start date
2013-06-30
Completion date
2016-02-29
Last updated
2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

CBF autoregulation, rSO2,doppler, TCD, delirium,

Brief summary

Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.

Detailed description

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

Interventions

None listed

Sponsors

Ornim Medical
CollaboratorINDUSTRY
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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-

Design outcomes

Primary

MeasureTime frameDescription
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 delirium3 days post opTo 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.

Secondary

MeasureTime frameDescription
recovery pattern of rSO23 post op daysTo 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.

Other

MeasureTime frameDescription
Can CBF autoregulation can be monitored using ultrasound compared with TCD3 days post opTo assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD
To evaluate the incidence of delirium in patients with impaired autoregulation3 days post opTo evaluate the incidence of delirium in patients with impaired autoregulation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026