SpO2 System Accuracy Testing With Different Sensors

SpO2 System Accuracy Testing

A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.

Study Overview

• Status: Completed
• Conditions: Pulse Oximetry
• Intervention / Treatment: Device: Pulse oximetry

Detailed Description

The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability to provide written informed consent or have a legally authorized representative provide written informed consent
• Subjects who are 18-55 years of age
• Subjects must be willing and able to comply with study procedures
• HbCO<3% (for smokers only)

Exclusion Criteria:

• Subject or a legally authorized representative is unable to provide written inform consent.
• Subjects that are considered morbidly obese (defined as BMI > 39.5),
• Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
• Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
• Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
• Subjects with known heart or cardiovascular conditions,
• Female subjects that are actively trying to get pregnant or are pregnant,
• Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
• Subjects with Systolic blood pressure >140mmHg,
• Subjects with Diastolic blood pressure >100mmHg,
• Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulse oximetry monitoring; The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.	Device: Pulse oximetry; Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy Root Mean Square (ARMS)	The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).	60 minutes

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Jeffrey Conner, GEHC

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2012
• Primary Completion (ACTUAL): February 15, 2013
• Study Completion (ACTUAL): February 15, 2013

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (ESTIMATE): June 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 118.02-2011-GES-0012