Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

University of Manitoba100 enrolled

Overview

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

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: 1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients 2. Determine the ability to derive patient-specific microvascular metrics using NIRS 3. Explore the relationship between microvascular metrics and ICU mortality

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Sepsis Shock Critical Illness

Interventions

Skeletal muscle and cerebral NIRS (research device)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

RECRUITING

Outcomes

Primary Outcomes

Recruitment

Recruitment of two patients per month from each study site

Time frame: 30 days

Secondary Outcomes

protocol adherence

collection of NIRS and clinical data for each monitoring session

Time frame: 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

Time frame: 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

Time frame: 14 days

Central Contacts

Asher Mendelson, MD, PhD

CONTACT

2047871634 asher.mendelson@umanitoba.ca

Data from ClinicalTrials.gov

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