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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2019-05-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring

NCT03935477

Shock Sepsis Surgery

UNKNOWN

Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®

NCT07022314

AKI - Acute Kidney Injury Cardiac Surgery Fluid Therapy +2 more

NOT_YET_RECRUITING

Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management

NCT03527758

Hypotension Brain Injuries Renal Failure +1 more

COMPLETED NA

Intraoperative Optimisation of Tissue Oxygenation

NCT01342900

Higk Risk Surgery

COMPLETED NA

Cerebral Perfusion Variation During Blood Pressure Changes in ICU

NCT05804773

Intensive Care Unit Syndrome

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High-risk Surgical Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IKORUS UP

Group Type EXPERIMENTAL

IKORUS UP system

Intervention Type DEVICE

Continuous assessment of the urethral microcirculation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IKORUS UP system

Continuous assessment of the urethral microcirculation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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…).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No