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

Not Applicable

Terminated

• Conditions: Mixed Venous Oxygen Saturation; Tissue Oxygenation
• Interventions: Device: Cerebral/Somatic Tissue Oximeter device; Device: Pulmonary artery catheter

• Registration Number: NCT00783952
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Study terminated because of inability to recruit subjects

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-31
• Study Start: 2008-11
• Study First Posted: 2008-11-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2016-10-28
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cerebral/Somatic Tissue Oximeter device	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
1	Pulmonary artery catheter	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

Primary Outcome Measures

Name	Time	Method
Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States