Continuous Non-invasive Assessment of Blood Pressure in Comparison to the Invasive Gold-standard and to the Sphygmomanometer.
| Registry | NCT03184285 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 50 (Actual) |
| Sponsor | University Hospital Schleswig-Holstein (Other) |
| Conditions | Bariatric Surgery, Arterial Blood Pressure |
| Interventions | baseline alert 1, Anti-Trendelenburg-position (ATB), ATB in narcosis, baseline in narcosis 1, passive leg raising, volume bolus substitution, baseline in narcosis 2, start capnoperitoneum, ATB plus capnoperitoneum, ATB plus capnoperitoneum plus volume bolus substitution, ATB loss of capnoperitoneum, baseline, baseline alert 2, torso position rising 30° at the beginning, torso position rising 30° at the end (Procedure) |
| Dates | start 2015-06-01, primary completion 2017-06-01, completion 2017-06-01, first posted 2017-06-12, last updated 2017-06-12 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Bariatric Surgery All trials for Arterial Blood Pressure All trials of baseline alert 1 All trials of Anti-Trendelenburg-position (ATB)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| bariatric surgery | Experimental | Procedure: baseline alert 1; Procedure: Anti-Trendelenburg-position (ATB); Procedure: ATB in narcosis; Procedure: baseline in narcosis 1; Procedure: passive leg raising; Procedure: volume bolus substitution; Procedure: baseline in narcosis 2; Procedure: start capnoperitoneum; Procedure: ATB plus capnoperitoneum; Procedure: ATB plus capnoperitoneum plus volume bolus substitution; Procedure: ATB loss of capnoperitoneum; Procedure: baseline; Procedure: baseline alert 2; Procedure: torso position rising 30° at the beginning; Procedure: torso position rising 30° at the end | baseline alert 1; Anti-Trendelenburg-position (ATB); Anti-Trendelenburg-position (ATB) in narcosis; baseline in narcosis 1; passive leg raising; volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); baseline in narcosis 2; start capnoperitoneum; Anti-Trendelenburg-position (ATB) plus capnoperitoneum; ATB plus capnoperitoneum plus volume bolus substitution (15 ml/kgKG Sterofundin balanced solution); ATB loss of capnoperitoneum; baseline in narcosis; baseline alert 2; torso position rising 30° at the beginning; torso position rising 30° at the end |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin | Kiel | Germany |