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

Tissue Oxygenation Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00783952
• Other study ID #: 2008-P-000420
• Status: Terminated
• Phase: N/A
• First received: October 30, 2008
• Last updated: September 22, 2015
• Start date: November 2008
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Study terminated because of inability to recruit subjects

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mixed Venous Oxygen Saturation
• Tissue Oxygenation

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No