Mixed Venous Oxygen Saturation, Tissue Oxygenation
Conditions
Keywords
Mixed venous oxygen saturation, Tissue oxygenation, Near infrared spectroscopy
Brief summary
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
Study terminated because of inability to recruit subjects
Interventions
DEVICECerebral/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.
Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations. | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Pulmonary Artery Catheters and Arterial Lines Patients with pulmonary artery catheters and arterial lines
'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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Patients With Pulmonary Artery Catheters and Arterial Lines |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Pulmonary Artery Catheters and Arterial Lines | 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 percentage of oxygen saturation | Standard Deviation 8 |
| 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. | 61.0 percentage of oxygen saturation | Standard Deviation 8.2 |