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临床试验/NCT04689516
NCT04689516已完成不适用

The Use of Thoracic Fluid Content as a Guide for 6% HES Infusion During Hypervolemic Hemodilution in Patients With Placenta Accreta. A Randomized Controlled Trial.

Cairo University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年12月24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
56
试验地点
2
主要终点
detection of pulmonary edema

研究概览

简要总结

Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical). The ICON device is often called "thoracic electrical bio-impedance" that based on measuring the changes in total resistance of the thorax to electric current and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, it provides an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.

Although many studies were done on the ability of TFC to detect pulmonary edema in preeclampsia, ARDS, heart failure, weaning from mechanical ventilation and during fluid management in prolonged surgery , yet, there is no study before was done on the use of TFC as a guide for fluid therapy during hypervolemic hemodilution in major obstetric surgery in patients with placenta accreta as one of the most common etiologies of life-threatening obstetric hemorrhage and the most common cause of peripartum hysterectomy

Aim of the work:

To use TFC as a guide for 6% HES infusion of hypervolemic hemodilution in patients with placenta accreta to avoid fluid overload.

Objectives:

  • To calculate LUS score at the end of infusion.
  • To evaluate TFC in k ohm-1.
  • To assess oxygen saturation, PO2 and P/F ratio in ABG.
  • To calculate the total infused volume in milliliters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-45 years old

排除标准

  • younger than 18 years,
  • ASA > or = III
  • patients with respiratory, cardiac disease, cardiac arrhythmias,
  • body mass index above 40 kg/m2
  • renal insufficiency,
  • hypovolemia denoted by PPV > 13 detected after start of mechanical ventilation,
  • preoperative baseline LUS score 10 or more,
  • TFC > or = 26 k ohm-1,
  • patients with neck or chest lesions that impair the application of cardiometry electrodes

结局指标

主要结局

detection of pulmonary edema

时间窗: 30 minutes after start infusion

thoracic fluid content estimation using cardiometry and lung ultrasound

次要结局

未报告次要终点

研究者

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

Sherif Abdullah Mohamed

Lecturer of anesthesia

Cairo University

研究点 (2)

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