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

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ClinicalTrials.gov Identifier: NCT00783952
Recruitment Status : Terminated (Inability to recruit subjects)
First Posted : November 3, 2008
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Mixed Venous Oxygen Saturation
Tissue Oxygenation
Interventions Device: Cerebral/Somatic Tissue Oximeter device
Device: Pulmonary artery catheter
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mixed Venous Oxygen and Calculation of Saturation
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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.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Patients With Pulmonary Artery Catheters and Arterial Lines
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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.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
59  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
1.Primary Outcome
Title Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Pulmonary Artery Catheters and Arterial Lines Patients With Cerebral/Somatic Tissue Oximeter Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
47.6  (8.0) 61.0  (8.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Pulmonary Artery Catheters and Arterial Lines
Hide Arm/Group Description

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.

All-Cause Mortality
Patients With Pulmonary Artery Catheters and Arterial Lines
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Pulmonary Artery Catheters and Arterial Lines
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Pulmonary Artery Catheters and Arterial Lines
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert M Kacmarek PhD, RRT
Organization: Massachusetts General Hospital
Phone: 617-314-2222
EMail: rkacmarek@partners.org
Layout table for additonal information
Responsible Party: Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00783952     History of Changes
Other Study ID Numbers: 2008-P-000420
First Submitted: October 30, 2008
First Posted: November 3, 2008
Results First Submitted: October 28, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017