Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

Study Overview
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Brief Summary
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Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.

Detailed Description
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This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors. NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records. The broad goals of the study are: Determine the feasibility of longitudinal NIRS monitoring in ICU patients Determine the ability to derive patient-specific microvascular metrics using NIRS Explore the relationship between microvascular metrics and ICU mortality

Official Title
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Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study

Conditions
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Sepsis, Shock, Critical Illness

Intervention / Treatment
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* Device: Skeletal muscle and cerebral NIRS (research device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to ICU Receiving invasive mechanical ventilation Exclusion Criteria: Body Mass Index >40 More than 24 hours has elapsed since ICU admission Death is deemed to be imminent and inevitable during the next 24 hours Known allergy to the textile components of the device Significant clinical jaundice, ecchymosis COVID positive microbiological result The treating clinician believes that participation in the domain would not be in the best interests of the patient Consent declined from patient or authorized third party

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>All patients | Device: Skeletal muscle and cerebral NIRS (research device)<br>* NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day.<br>* Other names: PortaLite (Artinis Inc, Netherlands);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Recruitment of two patients per month from each study site | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protocol adherence | collection of NIRS and clinical data for each monitoring session | 14 days | 
| NIRS and vital sign data quality | NIRS and vital sign data is >50% free of artifacts for >80% of recording sessions to enable further analysis | 14 days | 
| Optimal Map (MAPopt) derivation | when MAP and NIRS data available together, ability to derive MAPopt from >80% of recording sessions using correlation analysis | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-Infrared Spectroscopy