Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation
| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2008 | ||||
| Last Updated Date | November 5, 2012 | ||||
| Start Date ICMJE | November 2008 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determining the accuracy of mixed venous oxygen saturation obtained with a novel mathematical equation using arterial oxygen saturations and various local tissue oxygen saturations. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00783952 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation | ||||
| Official Title ICMJE | Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Device: '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. |
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| Study Arm (s) | 1
Patients with pulmonary artery catheters and arterial lines
Intervention: Device: 'Cerebral/Somatic Tissue Oximeter' device |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00783952 | ||||
| Other Study ID Numbers ICMJE | 2008-P-000420 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Robert M. Kacmarek, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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