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临床试验/NCT04934995
NCT04934995已完成不适用

Comparison of Arm and Ankle Blood Pressure During Cesarean Delivery: A Blood Pressure Cuffs Pilot Study

Ohio State University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月14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
100
试验地点
1
主要终点
Difference of SBP measured between arm and ankle during elective CD before SAB

研究概览

简要总结

This is a single center prospective self-control study to validate the effectiveness of left uterine displacement after subarachnoid block (SAB) with simultaneous measurements of blood pressure (BP) on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center

详细描述

In the last three decades, numerous interventions have been studied and implemented into our daily practice, such as pre-loading versus co-loading, phenylephrine versus ephedrine, and phenylephrine infusion versus intermittent boluses. In addition, the effectiveness of left uterine displacement (LUD) to improve blood flow and pressure remains unclear. Also, there are issues to be addressed on this regard, including:

  1. Poor placental perfusion from inadequate LUD due to the potential impact of supine hypotensive syndrome (SHS) secondary to aortocaval compression especially after SAB;
  2. Shivering during cesarean delivery (CD) resulting in inaccurate BP measurements, the incidence of shivering during CD is reported to be 21.9%. It is unclear the impact of shivering during CD on blood pressure (BP) measurements;
  3. Patient discomfort during BP measurements, calf > arm > ankle

The Investigators are conducting a single center prospective self-control study aiming to validate the effectiveness of LUD after SAB with simultaneous measurements of BP on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD). In addition, the Investigators will determine whether ankle BP correlates more accurately than arm SBP with the incidence of nausea/vomiting and category II or III fetal heart tracing and bradycardia after SAB and LUD under no shivering conditions and the impact of body mass index and antepartum estimation of newborn weight on SHS after the SAB.

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

入选标准

  • Age ≥ 18 years old
  • Women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia
  • American Society of Anesthesiologists Physical Status I-III
  • Body mass index during pregnancy ≥ 35 kg/m2
  • Able to consent in English language
  • Singleton pregnancy

排除标准

  • Women undergoing elective cesarean delivery at The Ohio State University Wexner Medical Center under anesthesia other than spinal anesthesia (i.e. general and/or epidural anesthesia)

结局指标

主要结局

Difference of SBP measured between arm and ankle during elective CD before SAB

时间窗: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).

Arm Systolic Blood Pressure values will be compared with the ankle SBP values before subarachnoid anesthesia. Baseline SBP will be measured pre-spinal anesthesia in supine position (after standard of care left uterine displacement maneuver is performed).

Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)

时间窗: Immediately after subarachnoid anesthesia block is completed

Arm Systolic Blood Pressure values will be compared with the ankle SBP values after subarachnoid anesthesia. Postspinal SBP will be measured in supine position, after LUD is performed

次要结局

  • Incidence of intraoperative vomiting in our patient population(Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge)
  • Incidence of intraoperative nausea in our patient population(Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge)

研究者

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

Ling-Qun Hu

Principal Investigator

Ohio State University

研究点 (1)

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