An interventional study of Cerebral/Somatic Tissue Oximeter device and Pulmonary artery catheter in Mixed Venous Oxygen Saturation and Tissue Oxygenation, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other
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.
Study terminated because of inability to recruit subjects
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: Pulmonary artery catheter
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.
Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.
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.
Time frame: 6 months
| Milestone | Mixed Venous Oxygen and Calculation of Saturation |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| percentage of oxygen saturation | Patients With Pulmonary Artery Catheters and Arterial Lines | Patients With Cerebral/Somatic Tissue Oximeter Device |
|---|---|---|
| Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations. | 47.6 ± 8.0 | 61.0 ± 8.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Pulmonary Artery Catheters and Arterial Lines | — | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Patients With Pulmonary Artery Catheters and Arterial Lines |
|---|---|
| Mean | 59 ± 15 |
| Sex: Female, Male(Participants) | Patients With Pulmonary Artery Catheters and Arterial Lines |
|---|---|
| Female | 4 |
| Male | 4 |
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital