Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

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

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-27

Study Completion Date

2026-05-31

Brief Summary

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

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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:

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

Conditions

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Sepsis Shock Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

All patients

Skeletal muscle and cerebral NIRS (research device)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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PortaMon (Artinis Inc, Netherlands) PortaLite (Artinis Inc, Netherlands)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No