Clinical trial NCT02476630: Thenar Tissue Oxygen Concentration (StO2): A Non-invasive Surrogate for Central Venous Oxygen Saturation (ScvO2)
Official title: Thenar Tissue Oxygen Concentration (StO2): A Non-invasive Surrogate for Central Venous Oxygen Saturation (ScvO2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Concentration Levels
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of tissue oxygen concentration (StO2) percentage
timeFrame: Day 1
Secondary outcomes:
measure: Comparison of thenar StO2 oxygen saturation calculations between central venous oxygen saturation (ScvO2) calculations.
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Childrens Hospital UF Health
state: Florida
Study officials:
affiliation: University of Florida , Gainesville, Florida, United States, 32610
name: Ravi Samraj, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Taylor DE, Simonson SG. Use of near-infrared spectroscopy to monitor tissue oxygenation. New Horiz. 1996 Nov;4(4):420-5.
citation: 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.