SpO2 System Accuracy Testing With Different Sensors

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01613222
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulse Oximetry	Device: Pulse oximetry	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: SpO2 System Accuracy Testing
• Actual Study Start Date: Jun 19, 2012
• Actual Primary Completion Date: Feb 15, 2013
• Actual Study Completion Date: Feb 15, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Accuracy Root Mean Square (ARMS) [60 minutes]

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 Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinimark	Louisville	Colorado	United States	80027

Sponsors and Collaborators

• GE Healthcare

Investigators

• Study Director: Jeffrey Conner, GEHC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01613222
• Other Study ID Numbers: 118.02-2011-GES-0012
• First Posted: Jun 7, 2012
• Last Update Posted: Feb 5, 2019
• Last Verified: Jan 1, 2019

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on June19, 2012 and the last subject was enrolled on February 15, 2013. The study was conducted at Clinimark, a human performance laboratory that tests physiological monitoring devices.

Arm/Group Title	Pulse Oximetry Monitoring
Arm/Group Description	Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
Period Title: Overall Study
STARTED	63
COMPLETED	51
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Pulse Oximetry Monitoring
Arm/Group Description	Pulse Oximetry Monitoring Single Arm
Overall Participants	51
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	51 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.4 (3.8)
Sex: Female, Male (Count of Participants)
Female	28 54.9%
Male	23 45.1%
Region of Enrollment (participants) [Number]
United States	51 100%
SpO2 (% oxygen) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% oxygen]	95.1 (1.6)

Outcome Measures

1. Primary Outcome

Title	Accuracy Root Mean Square (ARMS)
Description	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).
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

The data analyzed was SpO2 data pairs using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. Multiple data pairs were collected from each study participant, but not all sensors, patient monitors, co-oximeters and module configurations were used with each participant.

Arm/Group Title	Pulse Oximetry Monitoring Using SpO@ Sensors
Arm/Group Description	Pulse oximetry measurement using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules.
Measure Participants	51
Measure Number of Data Pairs	2826
TS-AAW Sensor + B40 Patient Monitor	1.488
TS-AAW Sensor + 3900 Oximeter	1.465
TS-AAW Sensor + Carescape V100 & UTrusignal V2	1.651
TS-AAW Sensor + Carescape V100	1.352
TS-AAW Sensor + EPRESTN	2.179
TS-AAW Sensor + M-NESTPR	1.813
TS-AAW Sensor + M-OSAT	1.496
TS-AAW Sensor + TruSat	1.612
TS-SA-D Sensor + TruSat	1.523
TS-AAW Sensor + TruffSat	1.286

Adverse Events

Time Frame	1 month
Arm/Group Title	TS-AAW Sensor + 3900 Oximeter		TS-AAW Sensor + B40 Patient Monitor		TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board		TS-AAW Sensor + Carescape V100		TS-AAW Sensor + EPRESTN		TS-AAW Sensor + M-NESTPR		TS-AAW Sensor + M-OSAT		TS-AAW Sensor + TruSat		TS-AAW Sensor + TuffSat		TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board
Arm/Group Description	Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.		Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
All Cause Mortality
	TS-AAW Sensor + 3900 Oximeter		TS-AAW Sensor + B40 Patient Monitor		TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board		TS-AAW Sensor + Carescape V100		TS-AAW Sensor + EPRESTN		TS-AAW Sensor + M-NESTPR		TS-AAW Sensor + M-OSAT		TS-AAW Sensor + TruSat		TS-AAW Sensor + TuffSat		TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)
Serious Adverse Events
	TS-AAW Sensor + 3900 Oximeter		TS-AAW Sensor + B40 Patient Monitor		TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board		TS-AAW Sensor + Carescape V100		TS-AAW Sensor + EPRESTN		TS-AAW Sensor + M-NESTPR		TS-AAW Sensor + M-OSAT		TS-AAW Sensor + TruSat		TS-AAW Sensor + TuffSat		TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	TS-AAW Sensor + 3900 Oximeter		TS-AAW Sensor + B40 Patient Monitor		TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board		TS-AAW Sensor + Carescape V100		TS-AAW Sensor + EPRESTN		TS-AAW Sensor + M-NESTPR		TS-AAW Sensor + M-OSAT		TS-AAW Sensor + TruSat		TS-AAW Sensor + TuffSat		TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor cannot require changes to the PI's disclosure, with the exception of requesting the removal of sponsor's confidential information. The study results themselves are not considered confidential information. Sponsor cannot extend the embargo beyond 60 days unless the PI's disclosure contains patentable subject matter, in which an embargo beyond 60 days may be necessary to allow for the filing of a patent application