Near Infrared Spectroscopy (St02)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01062685

Acronym

St02

Enrollment

186

Registered

2010-02-04

Start date

2009-01-31

Completion date

2010-01-31

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

septic shock, sepsis, St02, Near Infrared Spectroscopy, NIRS

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.

Interventions

DIAGNOSTIC_TESTNear-infrared spectroscopy assessment

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Organ Dysfunction and Severity of Illness	time 0 - 24 hrs

Secondary

Measure	Time frame
Mortality	In hospital

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026