To validate the Nexfin cardiac output monitor for morbidly obese patients undergoing elective surgery with the PiCCO monitor.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Level of agreement between Nexfin and PiCCO cardiac output measurements.
Secondary outcome
• Systemic vascular resistance
Background summary
The non invasive hemodynamic monitoring options in obese patients is limited.
Only intermittend bloodpressure measurements are availible. To enlarge the
array of options and extend the non invasive monitoring options in the future,
we want to validate the Nexfin monitor with the PICCO thermodulition monitor
(the gold standard for cardiac output measurements). The end goal is to improve
hemodynamic monitoring capabilities for patient safety, and to make non
invasive cardiac output measurements availible for future research in obese
patients.
Study objective
To validate the Nexfin cardiac output monitor for morbidly obese patients
undergoing elective surgery with the PiCCO monitor.
Study design
Prospective observational population study in the St. Lucas Andreas Ziekenhuis,
Amsterdam, the Netherlands.
Study burden and risks
The study subject do not have a direct benefit from participating in this
study. The burden consist mostly of the chance of complications.
The chance of a complication for placinf a central veneus acces is about 1%.
These are mostly hematomas around the acces site. Other comlications are
puncturing the lung or arterie. The comlication rate for these is also about 1
%. All procedures will be done ultrasound guided.
And nog more than three tries will be attempted.
The complication rate for an arterial line is about 1% aswell. This is also for
the most part heamatoma at the acces site.
Alle procedures will be doen will the patient is under anesthesia so placement
of the lines is not a big burden.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
• Indication for bariatric surgery
• Informed consent
• Age 18-70 years
• ASA classification I-III
Exclusion criteria
• Cardiac arrhythmia
• Valve replacement
• Inability to place intra-arterial lines for thermodilution measurements
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL45442.100.13 |