Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation

Study Overview
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Brief Summary
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The purpose of this study is to test a new way to measure the oxygen level in the mixed venous blood system (the system that carries blood collected from all over the body to the heart), which is a very important monitoring tool for the overall oxygen delivery to all our tissues. This new way measures the oxygen level in the mixed venous blood from outside the body, instead of measuring from the inside through a catheter (a thin, flexible plastic tube) that is placed by breaking the skin.

Detailed Description
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Study terminated because of inability to recruit subjects

Official Title
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Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations.

Conditions
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Mixed Venous Oxygen Saturation, Tissue Oxygenation

Intervention / Treatment
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* Device: Cerebral/Somatic Tissue Oximeter device
* Device: Pulmonary artery catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients already being monitored by a pulmonary artery catheter and an arterial line Exclusion Criteria: Patients with severe heart failure Patients with carbon monoxide or thiocyanate poisoning

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Mixed venous oxygen saturation measurement obtained from blood drawn from a pulmonary artery catheter.Calculation of mixed venous oxygen saturation from the measurement of peripheral oxygen saturations using multiple Cerebral/Somatic Tissue Oximeter device probes | Device: Cerebral/Somatic Tissue Oximeter device<br>* Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis. Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy.<br>Device: Pulmonary artery catheter<br>* Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations. | Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed venous oxygen saturation, Tissue oxygenation, Near infrared spectroscopy