Trial Outcomes & Findings for Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation (NCT NCT00783952)
NCT ID: NCT00783952
Last Updated: 2017-04-20
Results Overview
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.
TERMINATED
NA
8 participants
6 months
2017-04-20
Participant Flow
Participant milestones
| Measure |
Mixed Venous Oxygen and Calculation of Saturation
Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation
Baseline characteristics by cohort
| Measure |
Patients With Pulmonary Artery Catheters and Arterial Lines
n=8 Participants
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.
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsFour 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.
Outcome measures
| Measure |
Patients With Pulmonary Artery Catheters and Arterial Lines
n=8 Participants
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.
|
Patients With Cerebral/Somatic Tissue Oximeter Device
n=8 Participants
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.
|
|---|---|---|
|
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 8.0
|
61.0 percentage of oxygen saturation
Standard Deviation 8.2
|
Adverse Events
Patients With Pulmonary Artery Catheters and Arterial Lines
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert M Kacmarek PhD, RRT
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place