Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Bariatric Surgery
NCT ID: NCT03184272
Last Updated: 2017-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2015-06-01
2017-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuous Non-invasive Assessment of Blood Pressure in Bariatric Surgery
NCT03184285
Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
NCT03783052
Effect of Intraoperative Position Change on Hemodynamics and Electrocardiography
NCT06835166
NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery
NCT04830475
Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery
NCT06738875
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
bariatric surgery
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
baseline alert 1
measurement in supine position
Anti-Trendelenburg-position (ATB)
measurement under ATB
ATB in narcosis
measurement under ATB in narcosis
baseline in narcosis 1
measurement in supine position in narcosis
passive leg raising
measurement under passive leg raising
volume bolus substitution
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
baseline in narcosis 2
measurement in supine position
start capnoperitoneum
measurement in supine position
ATB plus capnoperitoneum
measurement under ATB plus capnoperitoneum
ATB plus capnoperitoneum plus volume bolus substitution
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
ATB loss of capnoperitoneum
measurement under ATB
baseline
measurement in supine position
baseline alert 2
measurement in supine position
torso position rising 30° at the beginning
measurement in the recovery unit
torso position rising 30° at the end
measurement in the recovery unit
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
baseline alert 1
measurement in supine position
Anti-Trendelenburg-position (ATB)
measurement under ATB
ATB in narcosis
measurement under ATB in narcosis
baseline in narcosis 1
measurement in supine position in narcosis
passive leg raising
measurement under passive leg raising
volume bolus substitution
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
baseline in narcosis 2
measurement in supine position
start capnoperitoneum
measurement in supine position
ATB plus capnoperitoneum
measurement under ATB plus capnoperitoneum
ATB plus capnoperitoneum plus volume bolus substitution
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
ATB loss of capnoperitoneum
measurement under ATB
baseline
measurement in supine position
baseline alert 2
measurement in supine position
torso position rising 30° at the beginning
measurement in the recovery unit
torso position rising 30° at the end
measurement in the recovery unit
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Schleswig-Holstein
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Jochen Renner
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, Deutschland (deu), Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lorenzen U, Pohlmann M, Hansen J, Klose P, Gruenewald M, Renner J, Elke G. Perioperative non-invasive versus semi-invasive cardiac index monitoring in patients with bariatric surgery - a prospective observational study. BMC Anesthesiol. 2020 Aug 10;20(1):196. doi: 10.1186/s12871-020-01110-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IN-BAR-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.