Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS) (MiMICSS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Shock; Critical Illness
• Intervention / Treatment: Device: Skeletal muscle and cerebral NIRS (research device)

Detailed Description

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 (Estimated): 100

Contacts and Locations

• Study Contact: Name: Asher Mendelson, MD, PhD; Phone Number: 2047871634; Email: asher.mendelson@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Recruiting
      • Health Sciences Centre Winnipeg
      • Contact: Asher Mendelson, MD PhD; Phone Number: 2047871634; Email: asher.mendelson@umanitoba.ca
      • Sub-Investigator: Frederick Zeiler, MD PhD
      • Sub-Investigator: Ryan Zarychanski, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the ICU receiving invasive mechanical ventilation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; All patients	Device: Skeletal muscle and cerebral NIRS (research 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.; Other Names: PortaMon (Artinis Inc, Netherlands); PortaLite (Artinis Inc, Netherlands)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	ICU mortality status	30 days
Hospital mortality	Hospital mortality	100 days

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Asher Mendelson, MD, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Near-Infrared Spectroscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Shock; Critical Illness
• Other Study ID Numbers: HS25043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No