IKORUS UP system
DeviceContinuous assessment of the urethral microcirculation
NCT Number: NCT03410069
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU Estaing, Clermont-Ferrand, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non inclusion criteria:
Continuous assessment of the urethral microcirculation
Time frame: 28 days
Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.
Time frame: 28 days
Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
Time frame: 28 days
Duration of useable signal acquisition (duration of perfusion index computation)
Time frame: 28 days
Quality of signal according to sensor position (proximal/distal)
Time frame: 28 days
Assessment of signal Quality, including Signal-to-noise ratio
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: SpO2
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: SVO2
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: lactactes
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: cardiac output
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)
Time frame: 28 days
Measures of hemodynamic /metabolic parameters: catecholamine infusions levels
Time frame: 28 days
Measures of hemodynamic or metabolic parameters: resuscitation events
Advanced Perfusion Diagnostics
Industry
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
Acronym: STEP UP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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