Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hemodynamic changes in cesarean section as measured by NICaS parameters.
研究概览
简要总结
In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery.
This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)
详细描述
This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.
Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.
Following obtaining an informed consent maternal cardiac output will be monitored.
The monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.
Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.
排除标准
- •Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.
结局指标
主要结局
Hemodynamic changes in cesarean section as measured by NICaS parameters.
时间窗: A year
This study's primary objective is to evaluate how anesthesia influences cardiac output during cesarean section deliveries
次要结局
- Hemodynamic changes measured by NICaS parameters and their correlation with pain in women undergoing cesarean sections as measured by VAS.(A year)