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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00783952 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Mixed Venous Oxygen Saturation Tissue Oxygenation |
Device: 'Cerebral/Somatic Tissue Oximeter' device |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations. |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Patients with pulmonary artery catheters and arterial lines
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert M Kacmarek, PhD | 617-7244480 | rkacmarek@partners.org |
| Contact: Demet Suleymanci, MD | 617-7244498 | dsuleymanci@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Robert Kacmarek, PhD 617-724-4480 rkacmarek@partners.org | |
| Contact: Demet Suleymanci, MD 617-724 4498 dsuleymanci@partners.org | |
| Principal Investigator: Robert Kacmarek, PhD, RRT | |
| Principal Investigator: | Robert Kacmarek, PhD, RRT | Massachusetts General Hospital |
More Information
| Responsible Party: | Robert Kacmarek, PhD, RRT, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00783952 History of Changes |
| Other Study ID Numbers: | 2008-P-000420 |
| Study First Received: | October 30, 2008 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Mixed venous oxygen saturation Tissue oxygenation Near infrared spectroscopy |
