Microcirculation, Tissue Perfusion, Urethral Perfusion Index
Conditions
Keywords
urethral perfusion index, tissue perfusion, microcirculation
Brief summary
We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.
Interventions
DEVICEurethal perfusion index monitoring
The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 45 years old * scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes) * indication for an arterial catheter * indication for an urinary catheter
Exclusion criteria
* Pregnancy * Planned surgery: nephrectomy, liver or kidney transplantation surgery * Patients who previously had surgery on the urethra or bladder * Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average intraoperative urethral perfusion index | Start of surgery until end of surgery |
Secondary
| Measure | Time frame |
|---|---|
| the lowest intraoperative 5-minute moving average urethral perfusion index | Start of surgery until end of surgery |
| the intraoperative area under the baseline urethral perfusion index | Start of surgery until end of surgery |
| the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index | Start of surgery until end of surgery |
| the absolute lowest intraoperative urethral perfusion index | Start of surgery until end of surgery |
| intraoperative area under a urethral perfusion index value 30% below baseline | Start of surgery until end of surgery |
| cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline | Start of surgery until end of surgery |
| the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index | Start of surgery until end of surgery |
Countries
Germany
Contacts
Primary ContactBernd Saugel, MD
Backup ContactMoritz Flick, MD
Outcome results
None listed