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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:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00783952
First received: October 30, 2008
Last updated: March 8, 2017
Last verified: March 2017
Results First Received: October 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Other
Conditions: Mixed Venous Oxygen Saturation
Tissue Oxygenation
Interventions: Device: Cerebral/Somatic Tissue Oximeter device
Device: Pulmonary artery catheter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Mixed Venous Oxygen and Calculation of Saturation
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Patients With Pulmonary Artery Catheters and Arterial Lines

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.


Baseline Measures
   Patients With Pulmonary Artery Catheters and Arterial Lines 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  50.0% 
Male      4  50.0% 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert M Kacmarek PhD, RRT
Organization: Massachusetts General Hospital
phone: 617-314-2222
e-mail: rkacmarek@partners.org



Responsible Party: Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00783952     History of Changes
Other Study ID Numbers: 2008-P-000420
Study First Received: October 30, 2008
Results First Received: October 28, 2016
Last Updated: March 8, 2017