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临床试验/NCT04131699
NCT04131699已完成不适用

Electrical Velocimetry (ICON Cardiometry) Assessment of Hemodynamic Changes With Different Inflation Pressures During Pediatric Thoracoscopic Surgery: A Pilot Study

Cairo University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年11月1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
12
试验地点
1
主要终点
change in Cardiac index

研究概览

简要总结

Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the surgical approach and the installation of carbon dioxide into the thoracic cavity can lead to alterations of normal acid-base status. Finally, surgical procedures in the chest, surgical traction or insufflation pressures impairs venous return and/or cardiac function, especially in neonates and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical, Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure (insufflation pressures 4,5 & 6 mmHg) during thoracoscopic surgeries in neonates and infants on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.

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
1 Day 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-II.
  • Age neonates and infants
  • Children undergoing thoracoscopic surgery surgeries.

排除标准

  • Parents' or guardians' refusal.
  • Left lateral positioning
  • Congenital heart diseases.

结局指标

主要结局

change in Cardiac index

时间窗: measured before inflation, 1 minute after inflation of the thoracic cavity at 4 mm Hg, 5 mm Hg and 6 mm Hg and after deflation

L/min/m2

次要结局

  • stroke volume(from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery)
  • non invasive blood pressure(from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure and after deflation till end of surgery)
  • heart rate(from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery)
  • cardiac output(from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery)
  • systemic vascular resistance(from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery)

研究者

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

Sherif Mohamed Abd el moneim Soaida, MD

Assistant professor

Cairo University

研究点 (1)

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