Shock
Conditions
Keywords
Tissue Perfusion, Noninvasive Monitoring, Near-infrared spectroscopy, CareGuide
Brief summary
This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).
Detailed description
Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A). Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.
Interventions
DEVICECareGuide™ device
CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
Sponsors
Reflectance Medical, Inc.
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who are: 1. To be admitted to the intensive care unit 2. At least 18 years of age 3. Men or Women 4. Informed consent from subject or surrogate 5. Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.
Exclusion criteria
Subjects with: 1. Body mass index \>37 2. Trauma (primary diagnosis) 3. Pregnancy 4. Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome) 5. Known untreated hypothyroidism 6. Known hypersensitivity to medical adhesives 7. Suspected carbon monoxide poisoning or methemoglobinemia 8. Goals of care restricting vital sign acquisition 9. Family member of investigators or study staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak systemic lactate | Duration of monitoring (< 1 week) | Cohort A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak systemic lactate | Duration of monitoring (< 1 week) | Cohort B |
| Temporal assessment of SmO2 and lactate | Duration of monitoring (< 1 week) | — |
| Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive) | Duration of monitoring (< 1 week) | — |
| Systemic pH | Duration of monitoring (< 1 week) | — |
Countries
United States
Outcome results
None listed