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

March 8, 2017 updated by: Robert M. Kacmarek, Massachusetts General Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study terminated because of inability to recruit subjects

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Mixed venous oxygen saturation measurement obtained from blood drawn from a pulmonary artery catheter.Calculation of mixed venous oxygen saturation from the measurement of peripheral oxygen saturations using multiple Cerebral/Somatic Tissue Oximeter device probes
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.

Device: Pulmonary artery catheter
Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Robert Kacmarek, PhD, RRT, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 31, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-P-000420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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