Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

Recruiting

• Conditions: Shock; Sepsis; Critical Illness
• Interventions: Device: Skeletal muscle and cerebral NIRS (research device)

• Registration Number: NCT05985525
• Lead Sponsor: University of Manitoba

Brief Summary

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

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 Timeline

• Study Start: 2022-05-27
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Skeletal muscle and cerebral NIRS (research device)	All patients

Primary Outcome Measures

Name	Time	Method
Recruitment	30 days	Recruitment of two patients per month from each study site

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Sciences Centre Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada