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

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ClinicalTrials.gov Identifier: NCT02476630
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Oxygen Concentration Levels 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
Actual Enrollment : 69 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Thenar Tissue Oxygen Concentration (StO2): A Non-invasive Surrogate for Central Venous Oxygen Saturation (ScvO2)
Actual Study Start Date : July 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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 Name: 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 Name: central venous oxygen saturation (ScvO2)




Primary Outcome Measures :
  1. Measurement of tissue oxygen concentration (StO2) percentage [ Time Frame: Day 1 ]
    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.


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



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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476630


Locations
United States, Florida
Shands Childrens Hospital UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Ravi Samraj, MD University of Florida , Gainesville, Florida, United States, 32610