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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oxygen Concentration Levels

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

StO2 measurement

Intervention Type DEVICE

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.

Blood Gases

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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InSpectraTM StO2 monitor central venous oxygen saturation (ScvO2)

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No