High-risk Surgical Patients Clinical Trial
Official title:
Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System
Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use
to maintain organ function. With growing evidence of lack of correlation between macro- and
micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are
often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion.
Thus, an approach incorporating tissue-perfusion based endpoints would represent a
significant step up to guide optimal resuscitation of critically-ill patients and to reduce
complications in high-risk surgery.
Current monitoring techniques, that complement systemic hemodynamics by focusing on regional
perfusion, still lack the required user-friendliness and/or clinical relevance to be
routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and
oxygenation is suboptimal, and implementation of the above-mentioned approaches of
resuscitation is still a challenge.
Urethral perfusion is likely to be early and significantly impaired during low-flow states
and thus represents a good "candidate" as a surrogate site to assess the perfusion of
visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler
manner than "deeper" organs. Nowadays, no practical methods or devices are available to
monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of
urethral perfusion could fill this need and enable enhanced management of patients in
Intensive Care Units (ICU) and Operating Rooms (OR).
The device consists of a modified Foley catheter equipped with a photoplethysmographic
sensor: the IKORUS UP probe.
The probe will be used by intensivists or anesthesiologists on high-risk surgical patients,
i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal
surgery.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00254150 -
A Therapy to Reduce Morbidity and Hospital Length of Stay of High-Risk Surgical Patients
|
Phase 2 | |
| Recruiting |
NCT06423833 -
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|
N/A |