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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Continuous assessment of the urethral microcirculation
CHU Estaing
Clermont-Ferrand, France
Lyon Sud Hospital
Lyon, France
Hopital Nord Marseille
Marseille, France
Hospital Saint Louis
Paris, France
Incidence of complications
Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.
Time frame: 28 days
Applicability of the procedure
Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
Time frame: 28 days
Signal acquisition
Duration of useable signal acquisition (duration of perfusion index computation)
Time frame: 28 days
Effect of the position of the sensor
Quality of signal according to sensor position (proximal/distal)
Time frame: 28 days
Quality of the signal
Assessment of signal Quality, including Signal-to-noise ratio
Time frame: 28 days
Evolution of mean arterial pressure
Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
Time frame: 28 days
Evolution of SpO2
Measures of hemodynamic /metabolic parameters: SpO2
Time frame: 28 days
Evolution of SVO2
Measures of hemodynamic /metabolic parameters: SVO2
Time frame: 28 days
Evolution of lactates dosages
Measures of hemodynamic /metabolic parameters: lactactes
Time frame: 28 days
Evolution of cardiac outputs
Measures of hemodynamic /metabolic parameters: cardiac output
Time frame: 28 days
Evolution of central venous pressure
Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)
Time frame: 28 days
Evolution of catecholamine infusions levels
Measures of hemodynamic /metabolic parameters: catecholamine infusions levels
Time frame: 28 days
Rate of resuscitation events
Measures of hemodynamic or metabolic parameters: resuscitation events
Time frame: 28 days
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