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SpO2 System Accuracy Testing With Different Sensors

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ClinicalTrials.gov Identifier: NCT01613222
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Pulse Oximetry
Intervention Device: Pulse oximetry
Enrollment 63
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.
Pre-assignment Details  
Arm/Group Title Pulse Oximetry Monitoring
Hide 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
Reason Not Completed
Physician Decision             1
Unable to place arterial line             1
Reused disposable sensors             10
Arm/Group Title Pulse Oximetry Monitoring
Hide Arm/Group Description Pulse Oximetry Monitoring Single Arm
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
63 subjects were enrolled. Data from 51 subjects was used for analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
0
   0.0%
Between 18 and 65 years
51
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
23.4  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
28
  54.9%
Male
23
  45.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
SpO2  
Mean (Standard Deviation)
Unit of measure:  % oxygen
Number Analyzed 51 participants
95.1  (1.6)
1.Primary Outcome
Title Accuracy Root Mean Square (ARMS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Pulse oximetry measurement using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules.
Overall Number of Participants Analyzed 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Data Pairs
2826
Mean (Full Range)
Unit of Measure: Accuracy Root Mean Square
TS-AAW Sensor + B40 Patient Monitor Number Analyzed 217 Number of Data Pairs [1] 
1.488
(-3.875 to 4.55)
TS-AAW Sensor + 3900 Oximeter Number Analyzed 2826 Number of Data Pairs [1] 
1.465
(-4.58 to 4.41)
TS-AAW Sensor + Carescape V100 & UTrusignal V2 Number Analyzed 2826 Number of Data Pairs [2] 
1.651
(-3.5 to 7.1)
TS-AAW Sensor + Carescape V100 Number Analyzed 2826 Number of Data Pairs [2] 
1.352
(-5.175 to 5)
TS-AAW Sensor + EPRESTN Number Analyzed 2826 Number of Data Pairs [2] 
2.179
(-7.005 to 8.42)
TS-AAW Sensor + M-NESTPR Number Analyzed 2826 Number of Data Pairs [1] 
1.813
(-7.7 to 3.65)
TS-AAW Sensor + M-OSAT Number Analyzed 2826 Number of Data Pairs [1] 
1.496
(-2.9 to 4.55)
TS-AAW Sensor + TruSat Number Analyzed 2826 Number of Data Pairs [2] 
1.612
(-4.865 to 7.71)
TS-SA-D Sensor + TruSat Number Analyzed 2826 Number of Data Pairs [2] 
1.523
(-3.65 to 7.07)
TS-AAW Sensor + TruffSat Number Analyzed 217 Number of Data Pairs [1] 
1.286
(-3.275 to 4.55)
[1]
10 participants
[2]
11 participants
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%) 
Show Serious Adverse Events Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Conner
Organization: GEHealthcare
Phone: 414-477-8374
EMail: Jeffrey.Conner@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01613222     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0012
First Submitted: June 5, 2012
First Posted: June 7, 2012
Results First Submitted: July 29, 2013
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019