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临床试验/NCT04491331
NCT04491331已完成不适用

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年6月8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
10
试验地点
1
主要终点
Change in Cardiac Index

研究概览

简要总结

Perioperative prone position may be associated with hemodynamic instability. The causes of instability have not yet been precisely elucidated. The aim of this study is to demonstrate physiological changes during prone positioning in healthy volunteers .

详细描述

The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained by increased systemic vascular resistance (SVR) in the majority of patients.

The aim of this study is to describe hemodynamic changes in two different surgical prone positions in 10 healthy non-anesthetized volunteers (flat position and using a support system allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards) and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger cuff.

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
All
接受健康志愿者

入选标准

  • age >18 years,
  • American Society of Anesthesiologists (ASA) Physical Status Classification I
  • agreement with study participation

排除标准

  • disagreement with study participation,
  • BMI over 40
  • pregnancy

结局指标

主要结局

Change in Cardiac Index

时间窗: 5 minutes

after changing supine to prone position

次要结局

  • Changes in vena jugularis diameter(5 minutes)
  • Changes in vena cava diameter(5 minutes)
  • Changes in vena saphena diameter(5 minutes)
  • Changes in vena cephalica diameter(5 minutes)

研究者

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

Dostalova Vlasta, MD, PhD

Principal investigator

University Hospital Hradec Kralove

研究点 (1)

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