Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Bariatric Surgery
Accuracy of Non-invasive Assessment of Cardiac Output and Fluid Responsiveness in Patients Undergoing Bariatric Procedures.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 3, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedJune 12, 2017
June 1, 2017
2 years
June 3, 2017
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Non-invasive assessment of fluid responsiveness using Nexfin technology
From the beginning of surgery to admission to the PACU, approximately 4 hours
Study Arms (1)
bariatric surgery
EXPERIMENTALbaseline 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
Interventions
measurement in supine position
measurement under ATB
measurement under ATB in narcosis
measurement in supine position in narcosis
measurement under passive leg raising
measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
measurement in supine position
measurement in supine position
measurement under ATB plus capnoperitoneum
measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
measurement under ATB
measurement in supine position
measurement in supine position
measurement in the recovery unit
measurement in the recovery unit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, Deutschland (deu), 24105, Germany
Related Publications (1)
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.
PMID: 32778047DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 3, 2017
First Posted
June 12, 2017
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 12, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share