Near Infrared Spectroscopy (NIRS) to Measure Tissue Oxygen Saturation (St02)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Organ Dysfunction and Severity of Illness
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Organ Dysfunction and Severity of Illness
Time Frame: time 0 - 24 hrs
Secondary Outcomes
- Mortality(In hospital)
Investigators
Nathan Shapiro
Associate Professor of Medicine
Beth Israel Deaconess Medical Center