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临床试验/NCT04112719
NCT04112719已完成不适用

Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月1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
50
试验地点
1
主要终点
Cardiac output (liters/minute)

研究概览

简要总结

In pregnant term patients, we intent to use a non invasive cardiac output monitor to detect the changes in cardiac output as the patient is being placed in different positions.

The patient will be placed on her back, flat, and in left lateral tilt at two different angles. Measurements of cardiac output will be recorded.

详细描述

Aortocaval compression compromising tissue perfusion has always been of a concern in term pregnant women undergoing caesarian delivery or regional anesthesia when placed in the supine position. It is believed that this phenomena happens when the gravid uterus compresses the inferior vena cava (IVC)resulting in decreased venous return and hence cardiac output (CO) leading to low placental perfusion and associated fetal heart rate changes.

Hence, due to these concerns, left lateral tilt is currently a common practice in obstetrics and it is believed to relief aortocaval compression and to improve blood flow to the fetus.

Supporting evidence for this intervention remains controversial, and shows conflicting results. Some studies suggest that lateral tilt does not affect neonatal outcomes (1) or changes in cardiac output in patients with no regional anesthesia (2). While others suggest it can actually increase the volume of the IVC, especially when the patient is tilted 30 degrees or more (3) and may lead to increases in CO (4).

Non-invasive hemodynamic monitoring (NICOM, Cheetah Medical), an FDA approved device, is currently being used to detect changes in CO in the United States. Its use has been validated in different clinical settings (5,6).

Our hypothesis is that CO is increased in pregnant women that were placed in the lateral tilt position.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women between the ages of 18-
  • Elective repeat cesarean section or induction of labor.

排除标准

  • Incarcerated patients
  • Patient unwilling or unable to provide consent
  • Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians).

结局指标

主要结局

Cardiac output (liters/minute)

时间窗: 20 minutes

Changes in cardiac output while patient in placed in lateral tilt at 30 degrees

次要结局

  • Blood pressure (mm Hg)(80 minutes)
  • Fetal heart rate abnormalities (beats/minute)(80 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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