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OpenTrials
Completed

NCT Number: NCT02084394

Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 3 days post op

    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.

Secondary outcomes

  1. recovery pattern of rSO2

    Time frame: 3 post op days

    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.

Other outcomes

  1. Can CBF autoregulation can be monitored using ultrasound compared with TCD

    Time frame: 3 days post op

    To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD

  2. To evaluate the incidence of delirium in patients with impaired autoregulation

    Time frame: 3 days post op

    To evaluate the incidence of delirium in patients with impaired autoregulation

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Ornim Medical

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 12, 2014
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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