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

NCT00783952 | Terminated Results

• 1 other identifier: 2008-P-000420
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Venous Oxygen Saturation; Tissue Oxygenation

Keywords

Mixed venous oxygen saturation; Tissue oxygenation; Near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

1

OTHER

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; Device: Pulmonary artery catheter

Interventions

Cerebral/Somatic Tissue Oximeter device 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.

1

Pulmonary artery catheter DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients already being monitored by a pulmonary artery catheter and an arterial line

You may not qualify if:

• Patients with severe heart failure
• Patients with carbon monoxide or thiocyanate poisoning

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Robert M Kacmarek PhD, RRT
• Organization: Massachusetts General Hospital

rkacmarek@partners.org

617-314-2222

Study Officials

• Robert Kacmarek, PhD, RRT

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, Director of Respiratory Care Services

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Locations

US (1)