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Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation

This study has been terminated.
(Inability to recruit subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00783952
First Posted: November 3, 2008
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
October 30, 2008
November 3, 2008
October 28, 2016
April 20, 2017
April 20, 2017
November 2008
January 2013   (Final data collection date for primary outcome measure)
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 ]
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. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00783952 on ClinicalTrials.gov Archive Site
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Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation
Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations.
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Mixed Venous Oxygen Saturation
  • Tissue Oxygenation
  • 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.

  • Device: Pulmonary artery catheter
    Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.
1
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
Interventions:
  • Device: Cerebral/Somatic Tissue Oximeter device
  • Device: Pulmonary artery catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00783952
2008-P-000420
No
Not Provided
Not Provided
Robert M. Kacmarek, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Robert Kacmarek, PhD, RRT Massachusetts General Hospital
Massachusetts General Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP