Bariatric Surgery Clinical Trial
Official title:
Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.
Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat measurement methods for the determination of arterial blood pressure in patients undergoing bariatric surgery.
Comparison between non-invasive discontinuous blood pressure measurement using a
sphygomanometric blood pressure cuff, and continuous non-invasive and invasive beat to beat
blood pressure measurement methods(Nexfin© and FloTrac©).
Bariatric patients show limitations regarding the conventional monitoring options with ECG
derivation, pulse oxymetric oxygen saturation and sphygmomanometric blood pressure
measurement. From a clinical point of view this results in an invasive arterial blood
pressure monitoring . In addition to that, intraoperative extreme changes of the patients
position on the table combined with the applied pneumoperitoneum during the minimally
invasive laparoscopic surgery can significantly influence the cardiovascular parameters. An
invasive arterial blood pressure monitoring is able to reproduce the blood pressure by
stroke, but it does not give any information about the cardiac output. The sphygmomanometric
blood pressure measurement also entails the risk of insufficient detection of a hypotonic
phase in the measurement. Additional monitoring systems are currently available, which are
capable of measuring completely non-invasive or semi-invasively different cardiovascular
parameters such as cardiac output (CO) and fluid responsiveness. In this study, the
investigators will compare continuous and discontinuous cardiovascular monitoring procedures
and their parameters. The measurements take place at specific times, under defined changes
in the body position with the additional influence of the pneumoperitoneum.
These changes are recorded and compared at the same time during different measuring methods
preoperatively, intraoperatively and postoperatively. The non-invasive Nexfin© Monitoring
(Edwards Lifesciences) is to be evaluated and compared with further measurement methods
(FloTrac© (Edwards Lifesciences)) as well as the sphygmomanometric upper arm blood pressure
measurement. The investigators also compare the non-invasive and invasive continuous beat to
beat blood pressure measurement with conventional, discontinuous sphygomanometric upper arm
blood pressure measurement.
The planned study is the comparison of 3 different hemodynamic monitoring procedures. For
the evaluation the investigators use the method described by Bland and Altmann for
calculating the mean deviation (bias) and the precision (mean value ± 2 standard deviations.
In the case of multiple measurements , the modification of the Bland-Altman method is
applied (repeated measurements). The number of cases was determined with n = 60 patients,
followed by an intermediate evaluation. For a Bland-Altman analysis, the width w of the
confidence interval for the Limits of Agreement is calculated as w = 6.79 • σ • 1 / √n,
where n is number of cases and σ is the standard deviation. For a case count of n = 60, the
result is w = 0.88 • σ and thus for this explorative study a sufficiently large number. In
case of the dynamic variables, the percentage matching and the calculation of the kappa
index are also used for the statistical evaluation.
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