Pneumoperitoneum Clinical Trial
Official title:
The Influence of Pneumoperitoneum and Open Abdominal Surgery on Dynamic Preload Variables
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.
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.
Hemodynamic variables will be recorded prior to induction of anesthesia, after anesthesia
was induced, and at the initial time point of pneumoperitoneum/open abdomen.
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Observational Model: Cohort, Time Perspective: Prospective
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