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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IKORUS UP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IKORUS UP system | Device | Continuous assessment of the urethral microcirculation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Applicability of the procedure | Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician. | 28 days |
| Signal acquisition | Duration of useable signal acquisition (duration of perfusion index computation) |
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Inclusion criteria:
Non inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Allaouchiche, Prof | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Clermont-Ferrand | 63003 | France | |||
| Lyon Sud Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31691897 | Derived | Depret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2019 | |
| Reset | Jul 23, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2019 | Jul 23, 2019 |
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| 28 days |
| Effect of the position of the sensor | Quality of signal according to sensor position (proximal/distal) | 28 days |
| Quality of the signal | Assessment of signal Quality, including Signal-to-noise ratio | 28 days |
| Evolution of mean arterial pressure | Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP) | 28 days |
| Evolution of SpO2 | Measures of hemodynamic /metabolic parameters: SpO2 | 28 days |
| Evolution of SVO2 | Measures of hemodynamic /metabolic parameters: SVO2 | 28 days |
| Evolution of lactates dosages | Measures of hemodynamic /metabolic parameters: lactactes | 28 days |
| Evolution of cardiac outputs | Measures of hemodynamic /metabolic parameters: cardiac output | 28 days |
| Evolution of central venous pressure | Measures of hemodynamic /metabolic parameters: central venous pressure (CVP) | 28 days |
| Evolution of catecholamine infusions levels | Measures of hemodynamic /metabolic parameters: catecholamine infusions levels | 28 days |
| Rate of resuscitation events | Measures of hemodynamic or metabolic parameters: resuscitation events | 28 days |
| Lyon |
| 69310 |
| France |
| Hopital Nord Marseille | Marseille | 13015 | France |
| Hospital Saint Louis | Paris | France |