Intracranial Surgery, Postoperative Complications
Conditions
Keywords
blood viscosity, intracranial craniotomy, neurosurgery, cerebral oxygenation, postoperative complications, hemodynamics
Brief summary
This prospective observational study aims to evaluate the association between intraoperative blood viscosity and postoperative clinical outcomes in adult patients undergoing elective intracranial craniotomy. Blood viscosity is an important determinant of microcirculatory flow and cerebral perfusion, but its role in perioperative outcomes remains unclear. In this study, intraoperative blood viscosity and related hematologic parameters will be measured, and their relationships with cerebral oxygenation and postoperative complications will be analyzed. The study will enroll adult patients undergoing elective intracranial surgery at a single tertiary center. The findings of this study may improve understanding of perioperative hemodynamic and hemorheological factors and help identify potential risk markers for adverse postoperative outcomes.
Interventions
OTHERObservational Assessment of Blood Viscosity
No intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes.
Sponsors
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 80 years * Patients scheduled to undergo elective intracranial craniotomy * Patients requiring intraoperative arterial catheterization and routine arterial blood gas analysis * Patients who provide written informed consent
Exclusion criteria
* Emergency surgery * Patients in whom participation or follow-up is considered difficult by the investigator * Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with one or more postoperative composite complications within 30 days after surgery | Up to postoperative day 30 | Composite complication is defined as the occurrence of at least one of the following within 30 days after surgery: postoperative neurologic complications, respiratory complications, cardiovascular complications, acute kidney injury defined as Kidney Disease Improving Global Outcomes stage 1 or higher, infectious complications requiring intravenous antibiotics or a procedure, reoperation or major postoperative intervention, or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in high-shear blood viscosity from after induction of anesthesia to near the end of surgery | After induction of anesthesia and near the end of surgery | High-shear blood viscosity will be measured at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements. |
| Change in low-shear blood viscosity from after induction of anesthesia to near the end of surgery | After induction of anesthesia and near the end of surgery | Low-shear blood viscosity will be measured at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements. |
| Change in TODI from after induction of anesthesia to near the end of surgery | After induction of anesthesia and near the end of surgery | TODI will be measured or calculated at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements. |
| Intraoperative regional cerebral oxygen saturation desaturation burden | From after induction of anesthesia to end of surgery | Cumulative burden of intraoperative regional cerebral oxygen saturation below the predefined study threshold during surgery. |
| Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery | From after induction of anesthesia to end of surgery | Area under the predefined desaturation threshold curve for regional cerebral oxygen saturation during surgery |
| Number of participants with postoperative neurologic complications within 30 days after surgery | Up to postoperative day 30 | Postoperative neurologic complications include new or worsened focal neurologic deficit, postoperative cerebral infarction, postoperative intracranial hemorrhage, clinically significant cerebral edema, seizure requiring treatment, or decreased consciousness or delayed emergence requiring imaging or additional intervention. |
| Number of participants with postoperative respiratory complications within 30 days after surgery | Up to postoperative day 30 | Postoperative respiratory complications include pneumonia, reintubation, mechanical ventilation for more than 24 hours after surgery, pulmonary edema, or respiratory failure requiring treatment. |
| Number of participants with postoperative cardiovascular complications within 30 days after surgery | Up to postoperative day 30 | Postoperative cardiovascular complications include myocardial infarction, new arrhythmia requiring treatment, or other clinically significant circulatory complications. |
| Number of participants with acute kidney injury within 30 days after surgery | Up to postoperative day 30 | Acute kidney injury is defined as Kidney Disease Improving Global Outcomes stage 1 or higher within 30 days after surgery. |
| Number of participants with postoperative infectious complications within 30 days after surgery | Up to postoperative day 30 | Postoperative infectious complications are defined as infections requiring intravenous antibiotics or a procedure within 30 days after surgery. |
| Number of participants requiring reoperation or major postoperative intervention within 30 days after surgery | Up to postoperative day 30 | Reoperation or major postoperative intervention occurring within 30 days after surgery. |
| Number of participants with all-cause mortality within 30 days after surgery | Up to postoperative day 30 | All-cause death occurring within 30 days after surgery. |
Countries
South Korea
Contacts
CONTACTJi-Hoon Sim, MD
Outcome results
None listed