Preoperative Transcranial Doppler as a Predictor for Delirium Following On-pump Cardiac Surgery

NCT ID: NCT02478736

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. Another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.

Detailed Description

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Conditions

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Postoperative Delirium After On-pump Cardiac Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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delirium group

the patients with delirum after on-pump cardiac surgery

No actual intervention

Intervention Type OTHER

Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.

no delirium group

the patients without delirum after on-pump cardiac surgery

No actual intervention

Intervention Type OTHER

Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.

Interventions

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No actual intervention

Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\. Patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery

Exclusion Criteria

1. No communication possible due to a language barrier or deafness
2. Patients diagnosed with neurocognitive disorders or psychiatric diseases (MMSE or Geriatric Depression Scale cannot be checked before surgery)
3. Patients with unstable hemodynamics or intubated before surgery
4. Patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by CT angiography or MR angiography
5. Patients diagnosed with stroke, TIA or neurologic diseases (e.g. Parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0319

Identifier Type: -

Identifier Source: org_study_id

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