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This prospective randomized controlled trial evaluates whether individualized cardiac index-guided intraoperative hemodynamic management reduces postoperative transient ischemic episodes in pediatric patients undergoing encephaloduroarteriosynangiosis (EDAS) for Moyamoya disease. Patients are randomized 1:1 to goal-directed fluid therapy based on baseline cardiac index versus standard arterial pressure-based management. The primary outcome is the incidence of transient ischemic episodes during hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac index guided hemodynamic management | Experimental |
| |
| Blood pressure guided hemodynamic management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Index-Guided Hemodynamic Management | Procedure | In the experimental arm, intraoperative hemodynamic management is guided by each patient's baseline cardiac index. Cardiac output is continuously monitored using the LiDCO system after arterial line insertion. Baseline cardiac index is calibrated using transthoracic echocardiography, and intraoperative fluids and vasoactive agents are adjusted to maintain cardiac index within ±20% of baseline. Standard anesthesia monitoring is provided to all patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of transient ischemic episodes during hospitalization | From end of surgery through postoperative hospital discharge, up to 7 days | Postoperative hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| MRI-confirmed postoperative cerebral infarction | From postoperative Day 0 through Day 7 | |
| MRI-confirmed intracranial hemorrhage | From postoperative Day 0 through Day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Bin Park | Contact | 820220723664 | jb4001@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009072 | Moyamoya Disease |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Blood Pressure-Guided Standard Hemodynamic Management | Procedure | In the control arm, intraoperative hemodynamic management follows conventional blood pressure-guided practice. After arterial line placement, the LiDCO device remains connected but the display is concealed during anesthesia. Fluids and vasoactive medications are adjusted according to standard MAP-based management. Standard anesthesia monitoring is provided to all patients. |
|
| Length of hospital stay |
Total number of days from the date of surgery to discharge. |
| From postoperative Day 0 through Day 7 |
| Intraoperative fluid volume administered | Total amount of crystalloid and colloid administered during surgery. | Intraoperative period |
| Intraoperative vasoactive agent dose | Total dose of vasoactive medications administered during anesthesia. | Intraoperative period |
| Intraoperative urine output | Total urine output measured during surgery. | Intraoperative period |
| Estimated blood loss | Total estimated blood loss recorded during the surgical procedure. | Intraoperative period |
| Duration of anesthesia | Time from induction of anesthesia to completion of anesthesia. | Intraoperative period |
| Duration of postoperative mechanical ventilation | Total duration of mechanical ventilation following surgery. | From end of surgery until extubation, assessed up to 24 hours |
| Length of ICU stay | Number of days spent in the ICU after surgery. | From postoperative Day 0 through ICU discharge, assessed up to 14 days |
| Percentage of anesthesia time with MAP deviating >20% from baseline | Proportion of total anesthesia time during which mean arterial pressure deviates more than 20% from the patient's ward baseline MAP. | Intraoperative period |
| Percentage of anesthesia time with cardiac index deviating >20% from baseline | Proportion of total anesthesia time during which cardiac index deviates more than 20% from the patient's baseline cardiac index measured via preoperative echocardiography. | Intraoperative period |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |