Near Infrared Spectroscopy (St02)

Study Overview
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Brief Summary
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The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.

Detailed Description
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Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving. There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death. This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.

Official Title
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Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)

Conditions
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Septic Shock

Intervention / Treatment
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* Diagnostic Test: Near-infrared spectroscopy assessment


Participation Criteria
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Eligibility Criteria
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There will be three cohorts enrolled in this study: (1) Septic Shock, (2) Sepsis and (3) Controls. Inclusion Criteria: Listed on the Cohorts description. Exclusion Criteria: All patient cohorts will share common set of exclusion criteria: Age < 18 years Pregnancy Established Do Not Resuscitate orders prior to enrollment Primary diagnosis of: Acute traumatic or burn injury Acute cerebrovascular event Acute coronary syndrome Acute pulmonary edema Cardiac dysrhythmia Acute and active gastrointestinal bleeding Acute drug overdose Requirement for immediate surgery Inability to obtain written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shock Cohort<br>The SHOCK cohort will meet the American College of Chest physicians/Society of Critical Care Medicine criteria for septic shock, specifically: 1) Suspected infection 2) Any two of four criteria of systemic inflammatory response: a. Temperature > 100.4° or < 96.8° F b. Heart rate > 90 beats/minute c. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg d. WBC >12,000 or < 4000 cells/µL or > 10% bands 3) Hypotension despite adequate fluid resuscitation: a. SBP < 90 mm Hg after 20cc/kg crystalloid | Diagnostic Test: Near-infrared spectroscopy assessment<br>* The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements. Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes.<br>* Other names: NIRS assessment;|
| Sepsis cohort<br>The SEPSIS cohort will to meet: 1) Suspected infection 2) Any two of four criteria of systemic inflammatory response: a. Temperature > 100.4° or < 96.8° F b. Heart rate > 90 beats/minute c. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg d. WBC >12,000 or < 4000 cells/µL or > 10% bands 3) Absence of refractory hypotension | Diagnostic Test: Near-infrared spectroscopy assessment<br>* The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements. Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes.<br>* Other names: NIRS assessment;|
| Non-Infected controls<br>The third cohort will be comprised of uninfected ED control patients who met the criteria of no suspected infection, no SIRS criteria met and no evidence of hypoperfusion that are age and sex matched on a 1:1 basis with the shock cohort. | Diagnostic Test: Near-infrared spectroscopy assessment<br>* The InSpectra StO2 Tissue Oxygenation Monitor (model 650; Hutchinson Technology, Hutchinson, MN, USA) with probes spaced at 15 mm will be utilized to obtain StO2 measurements. Following a minimum initial five-minute stabilization period, the initial StO2 will be measurement and then a Vasoocclusive Testing Procedure (VOT) will be performed using an automated tourniquet (Delfi Tourniquet System; Delfi Medical Innovations, Inc, Vancouver, BC, Canada), insufflated to 50 mmHg over the patient's SBP for a period of three minutes.<br>* Other names: NIRS assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ Dysfunction and Severity of Illness |  | time 0 - 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | In hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, sepsis, St02, Near Infrared Spectroscopy, NIRS