SpO2 System Accuracy Testing With Different Sensors

NCT ID: NCT01613222

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-19
• Study Completion Date: 2013-02-15

Brief Summary

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

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.

Conditions

Pulse Oximetry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulse oximetry

Intervention Type: DEVICE

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

Interventions

Pulse oximetry

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Conner

Role: STUDY_DIRECTOR

GEHC

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Other Identifiers

118.02-2011-GES-0012

Identifier Type: -

Identifier Source: org_study_id