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

This study has been terminated.
(Frequency of PA catheter use has decreased in our patient population, enrollment is extremely difficult.)
Sponsor:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00783952
First received: October 30, 2008
Last updated: September 17, 2014
Last verified: September 2014

October 30, 2008
September 17, 2014
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 ] [ Designated as safety issue: No ]
Same as current
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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
  • 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.

1
Patients with pulmonary artery catheters and arterial lines
Intervention: Device: 'Cerebral/Somatic Tissue Oximeter' device
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*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783952
2008-P-000420
No
Robert M. Kacmarek, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Robert Kacmarek, PhD, RRT Massachusetts General Hospital
Massachusetts General Hospital
September 2014

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