Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery; Hemodynamics
• Interventions: 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

• Registration Number: NCT03184272
• Lead Sponsor: University Hospital Schleswig-Holstein

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 cardiac output and fluid responsiveness in patients undergoing bariatric surgery.

Detailed Description

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 cardiac output and fluid responsiveness in patients undergoing bariatric surgery.

Bariatric patients show limitations regarding the conventional monitoring options with ECG derivation, pulse oxymetric oxygen saturation and sphygmo-manometric 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 volume 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 we use the method used 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.

Study Timeline

• Study Start: 2015-06-01
• Status Verified: 2017-06
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bariatric surgery	passive leg raising	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
bariatric surgery	baseline in narcosis 1	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
bariatric surgery	ATB plus capnoperitoneum plus volume bolus substitution	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
bariatric surgery	baseline alert 1	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
bariatric surgery	volume bolus substitution	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
bariatric surgery	ATB loss of capnoperitoneum	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
bariatric surgery	Anti-Trendelenburg-position (ATB)	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
bariatric surgery	ATB in narcosis	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
bariatric surgery	baseline in narcosis 2	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
bariatric surgery	start capnoperitoneum	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
bariatric surgery	ATB plus capnoperitoneum	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
bariatric surgery	baseline	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
bariatric surgery	baseline alert 2	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
bariatric surgery	torso position rising 30° at the beginning	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
bariatric surgery	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

Primary Outcome Measures

Name	Time	Method
Non-invasive cardiac output, i.e. stroke volume measurement using Nexfin technology	From the beginning of surgery to admission to the PACU, approximately 4 hours	Accuracy of non-invasive assessment of cardiac output, i.e. stroke volume index in comparison to an invasive standard using FloTrac Vigileo technology

Secondary Outcome Measures

Name	Time	Method
Non-invasive assessment of fluid responsiveness using Nexfin technology	From the beginning of surgery to admission to the PACU, approximately 4 hours	Accuracy of non-invasive assessment of fluid responsiveness (PPV, SVV) in comparison to an invasive standard using FloTrac Vigileo technology

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Kiel, Deutschland (DEU), Germany