Critical Illness, Sepsis, Shock
Conditions
Keywords
Near-Infrared Spectroscopy
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
Interventions
DEVICESkeletal 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.
Sponsors
University of Manitoba
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 30 days | Recruitment of two patients per month from each study site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | 30 days | ICU mortality status |
| Hospital mortality | 100 days | Hospital mortality |
Countries
Canada
Contacts
Primary ContactAsher Mendelson, MD, PhD
Outcome results
None listed