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

High-risk Surgical Patients Clinical Trial

— STEP UP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410069
• Other study ID #: 2017-A03466-47
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: May 7, 2019

Study information

• Verified date: May 2019
• Source: Advanced Perfusion Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 7, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…).

Related Conditions & MeSH terms

• Critical Illness
• High-risk Surgical Patients

Intervention

Device:
• IKORUS UP system
Continuous assessment of the urethral microcirculation

Locations

Country	Name	City	State
France	CHU Estaing	Clermont-Ferrand
France	Lyon Sud Hospital	Lyon
France	Hopital Nord Marseille	Marseille
France	Hospital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Perfusion Diagnostics	CEISO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications	Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.	28 days
Secondary	Applicability of the procedure	Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.	28 days
Secondary	Signal acquisition	Duration of useable signal acquisition (duration of perfusion index computation)	28 days
Secondary	Effect of the position of the sensor	Quality of signal according to sensor position (proximal/distal)	28 days
Secondary	Quality of the signal	Assessment of signal Quality, including Signal-to-noise ratio	28 days
Secondary	Evolution of mean arterial pressure	Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)	28 days
Secondary	Evolution of SpO2	Measures of hemodynamic /metabolic parameters: SpO2	28 days
Secondary	Evolution of SVO2	Measures of hemodynamic /metabolic parameters: SVO2	28 days
Secondary	Evolution of lactates dosages	Measures of hemodynamic /metabolic parameters: lactactes	28 days
Secondary	Evolution of cardiac outputs	Measures of hemodynamic /metabolic parameters: cardiac output	28 days
Secondary	Evolution of central venous pressure	Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)	28 days
Secondary	Evolution of catecholamine infusions levels	Measures of hemodynamic /metabolic parameters: catecholamine infusions levels	28 days
Secondary	Rate of resuscitation events	Measures of hemodynamic or metabolic parameters: resuscitation events	28 days