A Prospective Evaluation of Optic Nerve Sheath Diameter Changes Measured by Ultrasonography During Cardiopulmonary Bypass in Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Optic Nerve Sheath Diameter (ONSD)
研究概览
简要总结
During cardiopulmonary bypass (CPB) in open-heart surgery, direct measurement of intracranial pressure is not feasible. Evaluation of the optic nerve sheath diameter (ONSD) by ultrasonography is considered a reliable method for predicting increases in intracranial pressure. This study aims to investigate changes in ONSD in patients undergoing open-heart surgery with CPB.
详细描述
Several mechanisms during CPB-including inflammatory response, hemodilution, reperfusion injury, hypothermia-rewarming imbalances, and microembolism formation-can lead to increased intracranial pressure and cerebral edema. Ultrasonographic measurement of ONSD provides a noninvasive means of monitoring these changes. In this study, ONSD will be measured at different time points, while hemodynamic parameters, NIRS values, and arterial blood gas analyses will be recorded simultaneously. The primary objective is to evaluate changes in ONSD, and the secondary objective is to determine the potential impact of these changes on intracranial pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-85 years
- •Scheduled for elective open-heart surgery with cardiopulmonary bypass
- •Provided written informed consent
排除标准
- •Ocular or neurological complications related to diabetes
- •History of previous eye, brain, or thoracic surgery
- •Diagnosis of hydrocephalus, glaucoma, intracranial mass, or stroke
结局指标
主要结局
Change in Optic Nerve Sheath Diameter (ONSD)
时间窗: From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).
Evaluation of ONSD changes measured by ultrasonography to assess potential alterations in intracranial pressure during cardiopulmonary bypass.
次要结局
- Mean Arterial Pressure (MAP)(From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.)
- Central Venous Pressure (CVP)(From induction of anesthesia until the end of surgery, recorded simultaneously with OSD measurements.)
- Arterial Blood pH(From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).)
- Partial Pressure of Arterial Carbon Dioxide (PaCO₂)(From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).)
- Lactate(From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).)
- partial Pressure of Arterial Oxygen (PaO₂)(From tracheal intubation (baseline) until the end of surgery (approximately 4-6 hours); measurements at six predefined time points (post-intubation, CPB initiation, 15 min, 45 min, 15 min after CPB termination, end of surgery).)
研究者
Burak Omur
Assistant Professor of Anesthesiology
Medipol University