Clinical trial NCT03184285: Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery
Official title: Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Arterial Blood Pressure
Keywords: limitation in conventional monitoring
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Indication for bariatric surgery was made
* Classification according to the American Society of Anesthesiologists (ASA) 2-4
* Age \> 18 years
* Elective laparoscopic surgery
* Written declaration of consent
* Body Mass Index \> 30 kg / m²

Exclusion Criteria:

* atrial fibrillation
* cardiac arrhythmias
* aortic aneurysm \> 4,5 cm
* Peripheral arterial occlusive desease grade 3-4
* age \< 18 years
* missing or incorrect patient consent form
* cognitive or linguistic barriers

Primary outcomes:
measure: Non-invasive arterial blood pressure measurement in comparison to invasive measurement in bariatric surgery
timeFrame: From the beginning of surgery to admission to the PACU, approximately 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
Study officials:
name: Jochen Renner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen J, Pohlmann M, Beckmann JH, Klose P, Gruenewald M, Renner J, Lorenzen U, Elke G. Comparison of oscillometric, non-invasive and invasive arterial pressure monitoring in patients undergoing laparoscopic bariatric surgery - a secondary analysis of a prospective observational study. BMC Anesthesiol. 2022 Mar 28;22(1):83. doi: 10.1186/s12871-022-01619-3.