跳至主要内容
临床试验/NCT00573274
NCT00573274已完成不适用

Pilot Study Measuring Cardiac Output and Stroke Volume Using Non-Invasive Thoracic Impedance With the Physioflow Impedance Device in Pregnant Patients Undergoing Cesarean Section Under Spinal Anesthesia

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Continuous measurement of cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) changes.

研究概览

简要总结

Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic parameters classically requires insertion of a pulmonary artery catheter (PAC) into the heart. However, this invasive method carries significant complications and its use is now reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance device can be used as a reliable non-invasive monitor to measure hemodynamic parameters during elective CS under spinal anesthesia.

详细描述

The Physioflow Impedance device employs a continuous non-invasive method of measuring ten cardiac hemodynamic parameters including flow, resistance, contractility and fluid content. It involves the application of electrocardiogram (ECG) leads on the neck and the thorax to measure resistance of pulsatile blood flow. Its benefits are that it is non-invasive, low cost, and easy to operate. Thoracic impedance has been validated against the gold standard method of PAC. Although the Physioflow device has been validated in non-pregnant patients, its use in pregnant patients is very limited.

Moderate to severe hypotension, experienced by these awake patients, can cause significant undesirable symptoms of dizziness, shortness of breath, nausea and vomiting, and also compromise fetal well-being. The etiology of hypotension is multi-factorial,and it is postulated that decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) may precede decreases in blood pressure. Continuous measurement of CO and SV by the Physioflow Impedance device may provide a better understanding of the cause of hypotension so that future management of these patients may include pharmacological interventions used prior to hypotension in order to avoid any undesirable symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Women undergoing elective cesarean section
  • Women classified as ASA 1 & 2

排除标准

  • Patients unable to communicate in English
  • Patients with significant cardiac disease
  • Height less than 4 feet or greater than 7 feet
  • Weight less than 67 lbs or greater than 341 lbs

结局指标

主要结局

Continuous measurement of cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) changes.

时间窗: 60 minutes

次要结局

未报告次要终点

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Measuring Cardiac Output and Stroke Volume Using the... | 临床试验