Thenar Tissue Oxygen Concentration (StO2): A Non-invasive Surrogate for Central Venous Oxygen Saturation (ScvO2)

Oxygen concentration for patients undergoing cardiac catheterization and during admission to an intensive care unit is important outcome measure for clinical care. Currently, the tool used to monitor the oxygen concentration is a central venous access positioned in the superior vena cava or in the pulmonary artery to monitor the central venous oxygen saturation (ScvO2). However, it is invasive and not always possible due to a lack of a central line access. In this research study, the investigator would like use a noninvasive means for the ScvO2 by using the thenar tissue oxygen concentration (StO2). The primary aim for the study is to determine if the thenar StO2 correlates with ScvO2 and can serve as a noninvasive surrogate for ScvO2.

Study Overview

• Status: Completed
• Conditions: Oxygen Concentration Levels
• Intervention / Treatment: Device: StO2 measurement; Other: Blood Gases

Detailed Description

Participants will be undergoing a cardiac catheterization at Shands Children's Hospital or will be admitted to the intensive care unit, and as part of the clinical care either a central venous access positioned in the superior vena cava or in the pulmonary artery. As a part of the routine clinical care blood gases are frequently taken for continuous evaluation of therapy to monitor the central venous oxygen saturation (ScvO2). A measurement of thenar tissue oxygen concentration will be timed with a central venous blood gas draw to monitor the tissue oxygen concentration (StO2).

The StO2 measurement will be taken by using the InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. after applying the noninvasive clip on probe to the thenar eminence of the right hand to measure the StO2 level. After a stable reading is obtained for 60 seconds it will be recorded.

The two different measurements of oxygen concentration will be compared to determine if a correlation exists.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Childrens Hospital UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be undergoing a cardiac catheterization atan area Children's Hospital or will be admitted to the intensive care unit, and as part of the clinical care.

Description

Inclusion Criteria:

1. Age 1 month to 21 years of age admitted to the intensive care unit or undergo cardiac catheterization at Shands Children's Hospital and have a central venous access positioned in the superior vena cava or pulmonary artery.

Exclusion Criteria:

1. Age less than 1 month or more than 21 years
2. Burns of the hand
3. Infection of hand
4. Fracture of upper extremity
5. Hematoma of hand over thenar eminence

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study subjects; All participants will have a measurement of the tissue oxygen concentration (StO2) level after applying the noninvasive probe to the thenar eminence. This measurement is done at the same time as blood gases(ScvO2) from the central venous catheter is obtained. The StO2 measurement is documented once for the subject in the study.

Device: StO2 measurement; All participants will have a measurement of the tissue oxygen concentration (StO2) level after applying the noninvasive probe to the thenar eminence. This measurement is done at the same time as a blood gas from the central venous catheter is obtained. The StO2 measurement is documented once for the subject in the study.; Other Names: InSpectraTM StO2 monitor; Other: Blood Gases; All participants will have a measurement of the tissue oxygen concentration (StO2) level after applying the noninvasive probe to the thenar eminence. This measurement is done at the same time as a blood gas from the central venous catheter is obtained. The StO2 measurement is documented once for the subject in the study.; Other Names: central venous oxygen saturation (ScvO2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of tissue oxygen concentration (StO2) percentage	The use of the InSpectraTM StO2 monitor manufactured by Hutchinson Technology INC. will be used to measure the StO2 level after applying the noninvasive probe to the thenar eminence.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of thenar StO2 oxygen saturation calculations between central venous oxygen saturation (ScvO2) calculations.	The correlation between StO2 and ScvO2 will be determined by using Pearson's correlation test.	Day 1

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Ravi Samraj, MD, University of Florida , Gainesville, Florida, United States, 32610

Publications and helpful links

General Publications

• Beilman GJ, Groehler KE, Lazaron V, Ortner JP. Near-infrared spectroscopy measurement of regional tissue oxyhemoglobin saturation during hemorrhagic shock. Shock. 1999 Sep;12(3):196-200. doi: 10.1097/00024382-199909000-00005.
• Crookes BA, Cohn SM, Bloch S, Amortegui J, Manning R, Li P, Proctor MS, Hallal A, Blackbourne LH, Benjamin R, Soffer D, Habib F, Schulman CI, Duncan R, Proctor KG. Can near-infrared spectroscopy identify the severity of shock in trauma patients? J Trauma. 2005 Apr;58(4):806-13; discussion 813-6. doi: 10.1097/01.ta.0000158269.68409.1c.
• Taylor DE, Simonson SG. Use of near-infrared spectroscopy to monitor tissue oxygenation. New Horiz. 1996 Nov;4(4):420-5.
• Mesquida J, Masip J, Gili G, Artigas A, Baigorri F. Thenar oxygen saturation measured by near infrared spectroscopy as a noninvasive predictor of low central venous oxygen saturation in septic patients. Intensive Care Med. 2009 Jun;35(6):1106-9. doi: 10.1007/s00134-009-1410-y. Epub 2009 Jan 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB201500482

Drug and device information, study documents

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