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

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02476630
Collaborator
(none)
69
1
37
1.9

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Jul 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm 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)
  • Outcome Measures

    Primary Outcome Measures

    1. Measurement of tissue oxygen concentration (StO2) percentage [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. [Day 1]

      The correlation between StO2 and ScvO2 will be determined by using Pearson's correlation test.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02476630
    Other Study ID Numbers:
    • IRB201500482
    First Posted:
    Jun 19, 2015
    Last Update Posted:
    Aug 22, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 22, 2018