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

Postoperative Delirium After On-pump Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478736
• Other study ID #: 4-2015-0319
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: January 4, 2018
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium After On-pump Cardiac Surgery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the predictive power of perioperative MFV of MCA regarding postoperative delirium	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.	7 days from postoperation
Primary	the predictive power of periopertiver rSO2 values regarding postoperative delirium	To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery	7 days from postoperation