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)

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.

Study Overview

• Status: Completed
• Conditions: Delirium

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

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are under going cardiac bypass surgery with the use of cardiac perfusion

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-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3 days post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery pattern of rSO2	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.	3 post op days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Can CBF autoregulation can be monitored using ultrasound compared with TCD	To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD	3 days post op
To evaluate the incidence of delirium in patients with impaired autoregulation	To evaluate the incidence of delirium in patients with impaired autoregulation	3 days post op

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Ornim Medical
• Investigators: Principal Investigator: Kaushik Mandal, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: CBF autoregulation, rSO2,doppler, TCD, delirium,
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: NA_0007115