SpO2 System Accuracy Testing With Different Sensors

NCT01613222 | Completed Results

• 1 other identifier: 118.02-2011-GES-0012
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• 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 Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).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

Study Arms (1)

Pulse oximetry monitoring

EXPERIMENTAL

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

Interventions

Pulse oximetry DEVICE

Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.

Pulse oximetry monitoring

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Results Point of Contact

• Title: Jeffrey Conner
• Organization: GEHealthcare

Jeffrey.Conner@ge.com

414-477-8374

Study Officials

• Jeffrey Conner

  GEHC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: June 19, 2012
• Primary Completion: February 15, 2013
• Study Completion: February 15, 2013
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01

Locations

US (1)