Bariatric Surgery Clinical Trial
Official title:
Accuracy of Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Patients Undergoing Bariatric Procedures.
Verified date | June 2017 |
Source | University of Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin | Kiel | Deutschland (DEU) |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-invasive cardiac output, i.e. stroke volume measurement using Nexfin technology | Accuracy of non-invasive assessment of cardiac output, i.e. stroke volume index in comparison to an invasive standard using FloTrac Vigileo technology | From the beginning of surgery to admission to the PACU, approximately 4 hours | |
Secondary | Non-invasive assessment of fluid responsiveness using Nexfin technology | Accuracy of non-invasive assessment of fluid responsiveness (PPV, SVV) in comparison to an invasive standard using FloTrac Vigileo technology | From the beginning of surgery to admission to the PACU, approximately 4 hours |
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