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临床试验/NCT02408588
NCT02408588Enrolling By Invitation不适用

Evaluation of Compensatory Reserve in Obstetrical Patients

University of Colorado, Denver0 个研究点目标入组 600 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
600
主要终点
Changes in Central Volume Status

研究概览

简要总结

Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.

详细描述

The Investigators hypothesize that the Compensatory Reserve Index (CRI) algorithm will help to guide fluid management in women undergoing regional anesthesia, giving birth, and/or undergoing maternal fetal intervention surgery.

Specific aims:

Collect noninvasive physiological waveform data from patients undergoing regional anesthesia and either fetal intervention surgery or labor and delivery at Children's Hospital Colorado in order to:

  1. Determine how regional anesthesia influences CRI algorithm calculations
  2. Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery.
  3. Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding.
  4. Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension.
  5. Determine if there is a correlation between fetal heart rate abnormalities and CRI.
  6. Examine CRI associated with fetal monitoring.

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
0 Days 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 14 years - 44 years or 0 day old neonates born during the protocol
  • Patients undergoing regional anesthesia and either fetal intervention surgery or labor at Children's Hospital Colorado (CHCO) or University of Colorado Hospital (UCH)

排除标准

  • Incarcerated
  • Decisionally challenged
  • Patients who object at any time to participating in the study

结局指标

主要结局

Changes in Central Volume Status

时间窗: enrollment

Use pulse oximeter waveform data to determine central volume status changes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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