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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | All patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment of two patients per month from each study site | 30 days |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | ICU mortality status | 30 days |
| Hospital mortality | Hospital mortality | 100 days |
Inclusion Criteria:
Exclusion Criteria:
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Adults admitted to the ICU receiving invasive mechanical ventilation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asher Mendelson, MD, PhD | Contact | 2047871634 | asher.mendelson@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Asher Mendelson, MD, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre Winnipeg | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012769 | Shock |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |