Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients (STEP UP)

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

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 Overview

• Status: Completed
• Conditions: High-risk Surgical Patients
• Intervention / Treatment: Device: IKORUS UP system

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Estaing
  • Lyon, France, 69310
    • Lyon Sud Hospital
  • Marseille, France, 13015
    • Hopital Nord Marseille
  • Paris, France
    • Hospital Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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…).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IKORUS UP	Device: IKORUS UP system; Continuous assessment of the urethral microcirculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications	Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.	28 days

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Advanced Perfusion Diagnostics
• Collaborators: CEISO
• Investigators: Principal Investigator: Bernard Allaouchiche, Prof, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2018
• Primary Completion (ACTUAL): May 7, 2019
• Study Completion (ACTUAL): May 7, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (ACTUAL): January 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2017-A03466-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No