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临床试验/NCT02690688
NCT02690688Unknown不适用

The Influence of Pneumoperitoneum and Open Abdominal Surgery on Dynamic Preload Variables

University of Luebeck1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters

研究概览

简要总结

Dynamic preload variables like pulse-pressure and stroke volume variation may be used to predict fluid responsiveness in patients during controlled ventilation. Previous work has shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic preload parameters, suggestive of a fluid deficit - despite fluid status had not changed [van Lavieren M 2014].

The results of this study are limited by the fact that a non-invasive and uncalibrated hemodynamic monitoring system (Nexfin™) was used.

The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive surgical procedures with pneumoperitoneum.

详细描述

Hemodynamic monitoring is an essential part of modern anesthesia. Establishing and maintaining normovolemia during surgery is of high clinical relevance. Various studies suggest that dynamic preload parameters like stroke volume variation (SVV) and pulse pressure variation (PVV) are superior for interpretation and management of fluid status than static parameters like central venous pressure (CVP). Consequently, dynamic preload parameters have been integrated in recent guidelines for hemodynamic and fluid management.

Animal studies have shown reliable results for SVV and PVV to discriminate fluid-responder from non-responders if intraabdominal pressure is increased [Jacques D 2011]. In contrast to these findings, van Lavieren and colleagues have shown an inappropriate increase in measured dynamic preload parameters upon opening the abdomen using a non-invasive and uncalibrated system (Nexfin™). The present study thus aims to determine the effects of changes in abdominal pressure on dynamic preload parameters (PPV and SVV) (primary objective) employing an established invasive hemodynamic monitoring tool (Vigileo®, Edwards Lifescience) during open abdominal surgery as well as in minimal invasive surgical procedures using pneumoperitoneum.

Secondary objective is the effect of changes of cerebral oximetry readings during open and laparoscopic procedures and their relation to changes in cardiac index.

Elective ASA I-III patients scheduled for open and laparoscopic abdominal surgery will be enrolled according the planned operative procedure (open abdominal surgery or minimal invasive surgical procedures using pneumoperitoneum) and assignment. 60 patients (30/group) will be included according to a sample size calculation based on the data by van Lavieren.

Prior to induction of anesthesia an invasive blood pressure monitoring (radial artery) will be established and connected to a Vigileo® monitor (Edwards Lifescience). Additionally, bilateral optodes for the monitoring of cerebral oxygenation will be applied (INVOS, Somanetics). Ventilation, anesthesia and fluid management will be standardized.

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

  • ASA I-III patient
  • Signed agreement
  • Surgical procedure with open abdomen surgery or pneumperitoneum
  • Age > 18 Years
  • Intubation

排除标准

  • BMI ≥ 35 kg/m2
  • Need for catecholamines
  • Cardiac arrhythmia
  • Fluid resuscitation during measurements
  • Ongoing periduralcatheter-therapy
  • Missing agreement
  • Disposition for MH
  • Inclusion in other investigations < 30 days

结局指标

主要结局

Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters

时间窗: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery

次要结局

  • Influence of pneumoperitoneum or open abdominal surgery on cerebral oxymetry(Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery)
  • Correlation of cerebral oxymetry and cadiac index in pneumoperitoneum or open abdominal surgery(Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Heringlake

Professor of Anesthesiology, Deputy Director Cardiac Anesthesia, Dept. of Anesthesiology and Intensive Care Medicine

University of Luebeck

研究点 (1)

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