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

• ClinicalTrials.gov Identifier: NCT03410069
• Recruitment Status: Completed
• First Posted: January 25, 2018
• Last Update Posted: May 20, 2019
• Sponsor: Advanced Perfusion Diagnostics
• Collaborator: CEISO
• Information provided by (Responsible Party): Advanced Perfusion Diagnostics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
High-risk Surgical Patients	Device: IKORUS UP system	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: August 3, 2018
• Actual Primary Completion Date: May 7, 2019
• Actual Study Completion Date: May 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: IKORUS UP	Device: IKORUS UP system; Continuous assessment of the urethral microcirculation

Outcome Measures

Primary Outcome Measures :

1. Incidence of complications [ Time Frame: 28 days ]
   Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.

Secondary Outcome Measures :

1. Applicability of the procedure [ Time Frame: 28 days ]
   Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
2. Signal acquisition [ Time Frame: 28 days ]
   Duration of useable signal acquisition (duration of perfusion index computation)
3. Effect of the position of the sensor [ Time Frame: 28 days ]
   Quality of signal according to sensor position (proximal/distal)
4. Quality of the signal [ Time Frame: 28 days ]
   Assessment of signal Quality, including Signal-to-noise ratio
5. Evolution of mean arterial pressure [ Time Frame: 28 days ]
   Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
6. Evolution of SpO2 [ Time Frame: 28 days ]
   Measures of hemodynamic /metabolic parameters: SpO2
7. Evolution of SVO2 [ Time Frame: 28 days ]
   Measures of hemodynamic /metabolic parameters: SVO2
8. Evolution of lactates dosages [ Time Frame: 28 days ]
   Measures of hemodynamic /metabolic parameters: lactactes
9. Evolution of cardiac outputs [ Time Frame: 28 days ]
   Measures of hemodynamic /metabolic parameters: cardiac output
10. Evolution of central venous pressure [ Time Frame: 28 days ]
    Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)
11. Evolution of catecholamine infusions levels [ Time Frame: 28 days ]
    Measures of hemodynamic /metabolic parameters: catecholamine infusions levels
12. Rate of resuscitation events [ Time Frame: 28 days ]
    Measures of hemodynamic or metabolic parameters: resuscitation events

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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…).

Contacts and Locations

Locations

France

CHU Estaing

Clermont-Ferrand, France, 63003

Lyon Sud Hospital

Lyon, France, 69310

Hopital Nord Marseille

Marseille, France, 13015

Hospital Saint Louis

Paris, France

Sponsors and Collaborators

Advanced Perfusion Diagnostics

CEISO

Investigators

• Principal Investigator: Bernard Allaouchiche, Prof; Hospices Civils de Lyon

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dépret 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.

• Responsible Party: Advanced Perfusion Diagnostics
• ClinicalTrials.gov Identifier: NCT03410069
• Other Study ID Numbers: 2017-A03466-47
• First Posted: January 25, 2018
• Last Update Posted: May 20, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes