Transcranial Doppler as a Predictor of Postoperative Cognitive Dysfunction Following Cardiopulmonary Bypass

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

About this trial

Neurological dysfunction either transient or permanent is a major cause of morbidity and mortality after cardiopulmonary bypass, and cognitive dysfunction is more frequent in cardiac surgery than in non-cardiac procedures. Variations in cerebral blood flow and oxygen extraction are considered key contributing factors. Although pulsatile flow during bypass has shown benefits for renal function and recovery, its effects on postoperative neurological dysfunction and delirium remain unclear due to limited research. This study aims to evaluate the impact of pulsatile versus non-pulsatile cardiopulmonary bypass flow on POCD in adult CABG patients by measuring middle cerebral artery (MCA) flow using transcranial Doppler.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-70

Patients scheduled for isolated elective cardiopulmonary bypass surgery

Disqualifiers

Patients with carotid stenosis ≥50%

Emergency patients or those with a history of reoperation

Patients with a history of cerebrovascular events

Patients who do not provide consent

Trial population

Patients scheduled for isolated elective cardiopulmonary bypass surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcranial Doppler measurement of the middle cerebral artery

    Procedure/Surgery

    Transcranial Doppler examination was performed using a low-frequency (2-3.5 MHz) sector/cardiac probe through the transtemporal acoustic window. Middle cerebral artery (MCA) flow was identified in color Doppler mode at a depth of 3-7 cm with flow directed toward the probe. Pulsed-wave Doppler was applied, and peak systolic and end-diastolic velocities were recorded as the average of three measurements.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Group Pulsatile perfusion1 intervention
Group B: Group Non Pulsatile Perfusion1 intervention

Trial outcomes

Primary outcomes

1

Middle cerebral artery mean flow velocity measured by transcranial Doppler

Perioperative transcranial Doppler will be used to measure middle cerebral artery mean flow velocity at predefined time points: before anesthesia induction, after anesthesia induction, at the 10th, 20th, and 30th minutes after aortic cross-clamping, and after removal of the aortic cross-clamp, end of the surgery.

Time frame
Perioperative period
2

Postoperative delirium incidence (yes/no)

Postoperative delirium will be assessed as present or absent based on delirium screening (CAM-ICU in ICU; 3D-CAM on the ward) performed twice daily during postoperative days 1-5. Delirium is defined as at least one positive screen.

Time frame
Postoperative days 1-5
3

Postoperative cognitive dysfunction (MMSE score change)

The outcome is the change in MMSE score from the preoperative baseline assessment to postoperative day 5.

Time frame
Postoperative day 5

Secondary outcomes

1

Acute kidney injury stage (KDIGO)

Acute kidney injury will be defined and staged according to KDIGO criteria (stages 0-3) based on postoperative changes in serum creatinine and/or urine output

Time frame
Postoperative 24th hour
2

Duration of mechanical ventilation

The duration of ventilator support withdrawal in the postoperative intensive care unit

Time frame
Postoperative 24th hour
3

Length of stay in intensive care

The time the patient is transferred from intensive care to the ward

Time frame
within 30 days after surgery
4

Length of hospital stay

The time the patient is discharged home

Time frame
within 60 days after surgery

Other outcomes

Sponsors and contacts

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