跳至主要内容
临床试验/NCT02541656
NCT02541656已完成不适用

Dynamic Preload Dependence Indices in Laparoscopic Surgery

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Assess the validity of pulse pressure variation (in %)

研究概览

简要总结

A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.

The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Need to laparoscopic colectomy or hepatic resection
  • •Written informed consent

排除标准

  • •Cardiac arrhythmia
  • •Esophageal and cervical pathologies
  • •Radial artery Allen test negative
  • •Allergy to anesthesic treatment, to egg or soja
  • •Severe kidney failure (estimated glomerular filtration rate < 30 ml/min)
  • •Age < 18 years old
  • •Pregnancy

研究组 & 干预措施

preloaddependence indice after volume expansion in laparoscopy

Experimental

The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume.

干预措施: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique. (Procedure)

结局指标

主要结局

Assess the validity of pulse pressure variation (in %)

时间窗: at Day 0

Performing a fluid challenge after pneumoperitoneum insufflation, the association between pulse pressure variation value and stroke volume variation will be performed. Responder patients are defined by stroke volume augmentation \> 15 %

次要结局

  • Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .(at Day 0)
  • Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .(at Day 0)
  • Threshold value to predict fluid response in laparoscopic conditions.(at Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验