Clinical trial NCT03410069: Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-risk Surgical Patients
Lead sponsor: Advanced Perfusion Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2018-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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...).

Primary outcomes:
measure: Incidence of complications
timeFrame: 28 days
Secondary outcomes:
measure: Applicability of the procedure
timeFrame: 28 days
measure: Signal acquisition
timeFrame: 28 days
measure: Effect of the position of the sensor
timeFrame: 28 days
measure: Quality of the signal
timeFrame: 28 days
measure: Evolution of mean arterial pressure
timeFrame: 28 days
measure: Evolution of SpO2
timeFrame: 28 days
measure: Evolution of SVO2
timeFrame: 28 days
measure: Evolution of lactates dosages
timeFrame: 28 days
measure: Evolution of cardiac outputs
timeFrame: 28 days
measure: Evolution of central venous pressure
timeFrame: 28 days
measure: Evolution of catecholamine infusions levels
timeFrame: 28 days
measure: Rate of resuscitation events
timeFrame: 28 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Lyon
country: France
facility: Lyon Sud Hospital
city: Marseille
country: France
facility: Hopital Nord Marseille
city: Paris
country: France
facility: Hospital Saint Louis
Study officials:
affiliation: Hospices Civils de Lyon
name: Bernard Allaouchiche, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.