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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00783952
First received: October 30, 2008
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783952

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

No publications provided

Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00783952     History of Changes
Other Study ID Numbers: 2008-P-000420
Study First Received: October 30, 2008
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Mixed venous oxygen saturation
Tissue oxygenation
Near infrared spectroscopy

ClinicalTrials.gov processed this record on May 16, 2013