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

Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations.

Sponsors

Lead Sponsor: Massachusetts General Hospital

Source 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

Overall Status Terminated
Start Date November 2008
Completion Date January 2013
Primary Completion Date January 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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. 6 months
Enrollment 8
Condition
Intervention

Intervention Type: Device

Intervention Name: Cerebral/Somatic Tissue Oximeter device

Description: 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.

Arm Group Label: 1

Intervention Type: Device

Intervention Name: Pulmonary artery catheter

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

Arm Group Label: 1

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Robert Kacmarek, PhD, RRT Principal Investigator Massachusetts General Hospital
Location
Facility: Massachusetts General Hospital
Location Countries

United States

Verification Date

March 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts General Hospital

Investigator Full Name: Robert M. Kacmarek

Investigator Title: Professor of Anesthesia, Director of Respiratory Care Services

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: 1

Type: Other

Description: 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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov