Clinical Trials Directory

Trials / Completed

CompletedNCT01062685

Near Infrared Spectroscopy (St02)

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

Status
Completed
Phase
Study type
Observational
Enrollment
186 (actual)
Sponsor
Beth Israel Deaconess Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTNear-infrared spectroscopy assessmentThe 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.

Timeline

Start date
2009-01-01
Primary completion
2010-01-01
Completion
2010-01-01
First posted
2010-02-04
Last updated
2024-10-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01062685. Inclusion in this directory is not an endorsement.