Near Infrared Spectroscopy (St02) (St02)

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: Near-infrared spectroscopy assessment

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 Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department (ED) of one of three large, urban, tertiary care facilities.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shock Cohort; 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° Fb. Heart rate > 90 beats/minutec. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hgd. 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; 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.; Other Names: NIRS assessment
Sepsis cohort; 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° Fb. Heart rate > 90 beats/minutec. Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hgd. WBC >12,000 or < 4000 cells/µL or > 10% bands; 3) Absence of refractory hypotension	Diagnostic test: Near-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.; Other Names: NIRS assessment
Non-Infected controls; 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; 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.; Other Names: NIRS assessment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	In hospital

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Astute Medical, Inc.; Axis Shield Diagnostics Ltd; Hutchinson Technology Inc

Publications and helpful links

General Publications

• Skibsted S, Arnold R, Sherwin R, Singh S, Lundy D, Nelson T, Puskarich MA, Trzeciak S, Jones AE, Shapiro NI. The association of near infrared spectroscopy-derived StO2 measurements and biomarkers of endothelial activation in sepsis. Intern Emerg Med. 2013 Sep;8(6):529-36. doi: 10.1007/s11739-013-0973-3. Epub 2013 Jul 4.
• Shapiro NI, Arnold R, Sherwin R, O'Connor J, Najarro G, Singh S, Lundy D, Nelson T, Trzeciak SW, Jones AE; Emergency Medicine Shock Research Network (EMShockNet). The association of near-infrared spectroscopy-derived tissue oxygenation measurements with sepsis syndromes, organ dysfunction and mortality in emergency department patients with sepsis. Crit Care. 2011;15(5):R223. doi: 10.1186/cc10463. Epub 2011 Sep 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (ESTIMATE): February 4, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: septic shock; sepsis; Near Infrared Spectroscopy; NIRS; St02
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 2008P000323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No