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临床试验/NCT03555799
NCT03555799已完成不适用

Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement

Augusta University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
IVC diameter

研究概览

简要总结

The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.

详细描述

After approval by the Institutional Review Board and patient consent, term pregnant patients (>37 week gestation) admitted to the obstetric service of Augusta University Medical Center, who require administration of neuraxial analgesia for labor or regional anesthesia for cesarean section, will be included in the study. The consent will be obtained by the attending, resident or medical student in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. Demographic variables (age, BMI, Gravity, parity and gestation weeks) and hemodynamic variables (MAP and HR) will be recorded. All patients will be lying in supine position, breathing spontaneously. The ultrasound examination will be performed before commencement of the neuraxial procedure and will be repeated two minutes after administration of the neuraxial anesthetic. Ultrasound measurements will be made with a Sonosite Edge (Sonosite Inc. USA) machine and a C60X curved linear phased array transducer (Sonosite Inc.) set to abdominal mode. All measurements will be made by two attending anesthesiologists (ERP and AR) who have experience in transthoracic echocardiography, and a resident who receives the basic instruction to measure IVC diameter. The medical student will be present during the procedure and will ensure that the study echocardiographic views are taken.

The IVC will be visualized using a paramedian long-axis view via a subcostal approach according to guidelines of the American Society of Echocardiography. A two-dimensional image of the IVC will be obtained and pulsed wave Doppler will be used to differentiate from the aorta. Variations in IVC diameters will be assessed with M-mode applied 2 cm. distal to the right atrium. To ensure consistent measurements, each operator will take three images. The best quality images are chosen. Maximum and minimum IVC diameters during a single respiratory cycle will be measured.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients >37 weeks of gestation
  • Indication for neuraxial labor analgesia or regional anesthesia for cesarean section
  • Age older than 18 years
  • Pregnancy without diagnosed comorbidities
  • Exclusion criteria:
  • Unwillingness to participate in the study
  • Diagnosis of Hypertensive disorders of pregnancy
  • Diagnosis of cardiopulmonary disease
  • Allergy to US gel

排除标准

  • 未提供

结局指标

主要结局

IVC diameter

时间窗: 10 minutes

IVC diameter in centimeters during respiratory cycle

次要结局

  • Mean arterial pressure(30 minutes)
  • Nausea(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Efrain Riveros Perez, MD

Assistant Professor Department of Anesthesiology and Perioperative Medicine

Augusta University

研究点 (1)

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