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Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03410069
Acronym
STEP UP
Enrollment
30
Registered
2018-01-25
Start date
2018-08-03
Completion date
2019-05-07
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Surgical Patients

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.

Interventions

DEVICEIKORUS UP system

Continuous assessment of the urethral microcirculation

Sponsors

CEISO
CollaboratorINDUSTRY
Advanced Perfusion Diagnostics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 18 years of age or more, 2. Male or female, 3. High-Risk surgical patient, 4. Life expectancy expected to exceed 72 hours, 5. Willing to participate and signed informed consent, 6. Affiliation to the French social security system. Non inclusion criteria: 1. Pregnant or lactating woman, 2. History of recent urological surgery (bladder surgery, prostate surgery…), 3. Known stricture or impossible insertion last hospitalization, 4. Traumatic injury to the lower urinary tract, 5. History of radiotherapy of pelvic or genital area, 6. Genital malformation (Hypospadias…).

Design outcomes

Primary

MeasureTime frameDescription
Incidence of complications28 daysComplications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.

Secondary

MeasureTime frameDescription
Signal acquisition28 daysDuration of useable signal acquisition (duration of perfusion index computation)
Effect of the position of the sensor28 daysQuality of signal according to sensor position (proximal/distal)
Quality of the signal28 daysAssessment of signal Quality, including Signal-to-noise ratio
Evolution of mean arterial pressure28 daysMeasures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
Evolution of SpO228 daysMeasures of hemodynamic /metabolic parameters: SpO2
Applicability of the procedure28 daysEvaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
Evolution of lactates dosages28 daysMeasures of hemodynamic /metabolic parameters: lactactes
Evolution of cardiac outputs28 daysMeasures of hemodynamic /metabolic parameters: cardiac output
Evolution of central venous pressure28 daysMeasures of hemodynamic /metabolic parameters: central venous pressure (CVP)
Evolution of catecholamine infusions levels28 daysMeasures of hemodynamic /metabolic parameters: catecholamine infusions levels
Rate of resuscitation events28 daysMeasures of hemodynamic or metabolic parameters: resuscitation events
Evolution of SVO228 daysMeasures of hemodynamic /metabolic parameters: SVO2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026