Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients
- Conditions
- High-risk Surgical Patients
- Interventions
- Device: IKORUS UP system
- Registration Number
- NCT03410069
- Lead Sponsor
- Advanced Perfusion Diagnostics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IKORUS UP IKORUS UP system -
- Primary Outcome Measures
Name Time Method Incidence of complications 28 days Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.
- Secondary Outcome Measures
Name Time Method Signal acquisition 28 days Duration of useable signal acquisition (duration of perfusion index computation)
Evolution of SpO2 28 days Measures of hemodynamic /metabolic parameters: SpO2
Evolution of SVO2 28 days Measures of hemodynamic /metabolic parameters: SVO2
Evolution of mean arterial pressure 28 days Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
Evolution of catecholamine infusions levels 28 days Measures of hemodynamic /metabolic parameters: catecholamine infusions levels
Effect of the position of the sensor 28 days Quality of signal according to sensor position (proximal/distal)
Evolution of lactates dosages 28 days Measures of hemodynamic /metabolic parameters: lactactes
Evolution of cardiac outputs 28 days Measures of hemodynamic /metabolic parameters: cardiac output
Evolution of central venous pressure 28 days Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)
Applicability of the procedure 28 days Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
Quality of the signal 28 days Assessment of signal Quality, including Signal-to-noise ratio
Rate of resuscitation events 28 days Measures of hemodynamic or metabolic parameters: resuscitation events
Trial Locations
- Locations (4)
Hospital Saint Louis
🇫🇷Paris, France
Lyon Sud Hospital
🇫🇷Lyon, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Hopital Nord Marseille
🇫🇷Marseille, France