Try our beta test site

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

This study has been terminated.
(Inability to recruit subjects)
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital Identifier:
First received: October 30, 2008
Last updated: September 22, 2015
Last verified: September 2015
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.

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: November 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
Study terminated because of inability to recruit subjects

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00783952

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Robert Kacmarek, PhD, RRT Massachusetts General Hospital
  More Information

Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital Identifier: NCT00783952     History of Changes
Other Study ID Numbers: 2008-P-000420
Study First Received: October 30, 2008
Last Updated: September 22, 2015

Keywords provided by Massachusetts General Hospital:
Mixed venous oxygen saturation
Tissue oxygenation
Near infrared spectroscopy processed this record on March 29, 2017