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

Completed

• Conditions: Postoperative Delirium After On-pump Cardiac Surgery
• Interventions: Other: No actual intervention

• Registration Number: NCT02478736
• Lead Sponsor: Yonsei University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-23
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no delirium group	No actual intervention	the patients without delirum after on-pump cardiac surgery
delirium group	No actual intervention	the patients with delirum after on-pump cardiac surgery

Primary Outcome Measures

Name	Time	Method
the predictive power of periopertiver rSO2 values regarding postoperative delirium	7 days from postoperation	To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery
the predictive power of perioperative MFV of MCA regarding postoperative delirium	7 days from postoperation	The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. The investigators plan to evaluate whether perioperative rSO2 and/or MFV of MCA can predict postoperative delirium in patients undergoing the on-pump cardiac surgery and to assess the predictive power of perioperative rSO2/MFV of MCA regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 4 hours) and MVF of MCA was measured just before the induction of general anesthesia.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of