Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ultrasonographic fluid assessment
研究概览
简要总结
Preeclampsia is a multifocal syndrome reported in 2-8 % of pregnancies. It is diagnosed in the second half of pregnancy by two separate measurements of systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg in the same arm and proteinuria >300 mg in 24 h urine collection. The risk for serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage is 10 to 30 fold higher among parturients with severe preeclampsia.
Severe preeclampsia is defined by one or more of the following clinical features: severe hypertension (systolic arterial pressure 160 mmHg and/or diastolic arterial pressure 110 mmHg on more than one occasion at least 4 h apart while the patient is on bed rest, renal dysfunction (serum creatinine >1.1mg/dl or doubling of serum creatinine in the absence of another renal disease, platelet count less than <100,000 mm3, acute pulmonary edema, epigastric pain not responding to medical treatment, new-onset cerebral and visual manifestation, hemolysis, elevated liver enzymes and low platelet count syndrome (HELLP syndrome)
详细描述
Fluid resuscitation is a key determinant in the management of these parturients. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. In this setting, the use of noninvasive hemodynamic monitoring is associated with reduced mortality.
Point-of-care lung ultrasonography is used in many critical care settings as the initial diagnostic imaging study for patients with respiratory symptoms. It is highly sensitive for the diagnosis of pulmonary edema which may occur even without cardiomyopathy or heart failure.
The IVC is a highly compliant vessel that changes its diam¬eter in parallel with changes in blood volume and central venous pressure. Measurement of IVC diameter and col¬lapsibility index using ultrasound through a subcostal approach has been investigated in patients of various settings. The IVC-CI imaging technique may be used to assess the volume status in healthy parturients undergoing routine cesarean delivery as well as in high-risk parturients as preeclampsia.
Cerebral edema is predominantly vasogenic and may be related to the failure of cerebral autoregulation with subsequent hyperperfusion, blood-brain barrier disruption, and endothelial cell dysfunction. Ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of raised ICP.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy.
- •32 - 41 weeks gestational age.
- •Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
- •Elective cesarean delivery under spinal anesthesia.
排除标准
- •Body mass index (BMI) ≥40 kg/m
- •Significant cardiovascular disease
- •Other obstetrical problems
- •Other uteroplacental problems
- •Abruption placenta.
- •Already treated for acute lung pathology prior to enrollment.
- •Contraindications to spinal anesthesia.
- •INR >1.5 or PLT<100,000 /mm
- •Women presenting in labor.
- •Previous thoracic surgery.
- •Previous ocular surgery
- •Ocular trauma
- •Glaucoma.
- •Preoperative pulmonary disease:
- •Increased serum creatinine level ≥1.1 mg/dL.
研究组 & 干预措施
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Spinal Anesthesia (Procedure)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Intrathecal Bupivacaine (Drug)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Intrathecal Fentanyl (Drug)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Cesarean Delivery (Procedure)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: lung ultrasound scans (Radiation)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Ultrasound Assessment of the Inferior Vena Cava (Other)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Optic nerve sheath diameter (Other)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: ringer acetate (Drug)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Intravenous Ephedrine (Drug)
Lung Ultrasound (LUS) Examination
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
干预措施: Intravenous Syntocinon (Drug)
结局指标
主要结局
Ultrasonographic fluid assessment
时间窗: Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.
Detection of change in overall number of B lines (ECS) by lung ultrasound
次要结局
- Incidence of nausea and vomiting.(Intraoperative)
- Difference between overall number of b lines(baseline and 1hour post spinal)
- Inferior Vena Caval Diameters(Baseline, and at 1 and 2 hours post-spinal)
- Difference between optic nerve sheath diameter(baseline,at 1hour and at 2 hours of spinal anesthesia.)
- Neonatal Apgar score(5 min after delivery)
- Urine output(For 2 hours after spinal anesthesia)
- Oliguria(For 2 hours after spinal anesthesia)
- Ephedrine use(Intraoperative)
- Intraoperative bradycardia(Intraoperative)