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

NCT03410069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-20

No results posted yet for this study

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.

Conditions

  • High-risk Surgical Patients

Interventions

DEVICE

IKORUS UP system

Continuous assessment of the urethral microcirculation

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Advanced Perfusion Diagnostics

    lead INDUSTRY

Principal Investigators

  • Bernard Allaouchiche, Prof · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2019-05-07
Completion
2019-05-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410069 on ClinicalTrials.gov