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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-01-31

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.

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Detailed Description

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Study terminated because of inability to recruit subjects

Conditions

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Mixed Venous Oxygen Saturation Tissue Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Cerebral/Somatic Tissue Oximeter device

Intervention Type DEVICE

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.

Pulmonary artery catheter

Intervention Type DEVICE

Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.

Interventions

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Cerebral/Somatic Tissue Oximeter device

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.

Intervention Type DEVICE