Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01456702 |
| Other study ID # |
VoMo |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
September 29, 2011 |
| Last updated |
December 30, 2013 |
| Start date |
October 2014 |
| Est. completion date |
March 2016 |
Study information
| Verified date |
December 2013 |
| Source |
Charite University, Berlin, Germany |
| Contact |
Michael Sander, MD |
| Phone |
+49-30-450531 |
| Email |
michael.sander[@]charite.de |
| Is FDA regulated |
No |
| Health authority |
Germany: Ethics Commission |
| Study type |
Interventional
|
Clinical Trial Summary
It is difficulte to evaluate risk patients and to find the ideal intraoperative volume
management. It seems to be that ill patients benefit of a goal directed volume management.
The aim of this study is to implement the guidelines on perioperative cardiovascular
evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed
protocoll for volume management.
Description:
It is difficult in the majority of cases to estimate the correct intra-operative mass of
fluid therapy for each patient und needs a high degree of clinical experience. Among
circumstances and problems of surgery (kind of surgery, length of time, bleeding, loss of
liquid via wound) and kind of anesthesia, are also the concomitant diseases of patients
relevant for the action of all anesthetists. These concomitant diseases correct to detect
and to deduce corresponding consequences calls likewise for high clinical experience.
Furthermore, the pre-operative fasting is an important fact.
Considering all these influencing factors the anesthetist tends rather to apply to much
volume during surgery, followed by much more problems in PACU and / or intensive care unit.
However, how much volume is correct for which patient during which kind of surgery? How
could the investigators estimate the really intra vessel volume deficit? Which available
parameters are helpful, which monitoring is useful? These questions confront daily every
anesthetist.
Monitoring of clinical "traditional" factors such as diuresis, blood pressure und heart rate
are from experience to inexactly. Actually exist in the experts no uniform opinion about the
kind and amount of fluid administration, which to apply, as well as the adequate monitoring.
The central venous pressure, a commonly used parameter, is falling more and more behind.
Cardiac filling pressures correlate bad with filling volume and are unsuitable parameters
for fluid therapy. It seems that dynamic parameters such as stroke volume (SV) and stroke
volume variation (SVV) are better markers. SV and SVV could be measured by usual invasive
blood pressure via LiDCO- or FloTrac-Monitoring.
In the study the investigators would show, that it is necessary to optimize processes
already in the anesthetic ambulance, to evaluate patients with theirs concomitant diseases
correctly followed by an improvement of intra-operative processes.
With the help of questionnaire is to be better structured and classified the cardiac risk of
patients in accordance with the actually ACC / AHA guidelines (8). Depending surgery risk,
the development of intra-operative monitoring happens standardized preoperatively (NIBP vs.
IBP vs. SVV via FlowTrac or LiDCO). The intra-operative fluid regime will be performing in
the group of NIBP and IBP on the basis of standard operating procedures (SOP) as well as in
the group of SVV on the basis of a targeted-volume protocol.
There are a lot of surgeries with an increased fluid turnover and increased risk for cardiac
complication. This demonstrated study limits the kind of surgeries on orthopedic operations
with different requirement of intra-operative volume.
Hypothesis The daily challenge of each anesthetic is the correctly estimate of volume status
during surgery. Multiple factors such as concomitant diseases, pre-operative fluid fasting,
anesthesia as well as circumstances of surgery inclusive bleeding risk have an important
influence followed by difficult peri-operative management.
The aim of this study is the improvement of peri-operative fluid management due to process
optimisation already in the anesthetic ambulance included cardiac risk factors of patients
followed by intra-operative fluid protocol. Primary outcome parameters are administered
fluid volume (including blood transfusion), and secondary measured by amount of blood loss,
postoperatively frequency of PONV, delir as well as PACU and ICU stay.
The investigator believes that the investigators could reduce the intra-operative fluid
volume as well as blood loss due to these process optimization followed by increase patient
satisfaction. Furthermore, the investigators could possibly reduce the PACU and ICU stay.
