Trial Outcomes & Findings for SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry (NCT NCT03565679)

NCT ID: NCT03565679

Last Updated: 2019-06-18

Results Overview

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meett the 3% specification for each Medline Renewal Reprocessed pulse oximetry sensor style.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2019-06-18

Participant Flow

Participant milestones

Measure	MEDLINE RENEWAL PULSE OXIMETRY and Reference CO-oximetery Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance. Reprocessed Oximeter: is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information. Whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. Reference Oximeter: A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

Baseline characteristics by cohort

Measure	MEDLINE RENEWAL PULSE OXIMETRY& Reference CO-oximetry Sensors n=10 Participants Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance. Reprocessed Oximeter: is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information. A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. Reference Oximeter: A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
Age, Continuous	27.58 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Over 70 - 100% an ARMS ≤ 3% in non-motion conditions - Pass result

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.

The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meett the 3% specification for each Medline Renewal Reprocessed pulse oximetry sensor style.

Outcome measures

Measure	Masimo SpO2 Adhesive Sensors, Adtx (1859) n=10 Participants Medline ReNewal Reprocessed Masimo SpO2 Adhesive Sensors, Adtx (1859) compared to Reference CO-Oximetry (functional SaO2)	Masimo SpO2 Adhesive Sensors, Neo (2329) n=10 Participants Medline ReNewal Reprocessed Masimo SpO2 Adhesive Sensors, Neo (2329)Comparison to Reference CO-Oximetry (functional SaO2)	Covidien Nellcor SpO2 Sensor, MAX-A n=10 Participants Medline ReNewal Reprocessed Covidien Nellcor SpO2 Sensor, MAX-AComparison to Reference CO-Oximetry (functional SaO2)	Covidien Nellcor SpO2 Sensor, MAX-N n=10 Participants Medline ReNewal Reprocessed Covidien Nellcor SpO2 Sensor, MAX-N Comparison to Reference CO-Oximetry (functional SaO2)
SpO2 Percentage Specification	1.8 Percentage of SpO2	1.7 Percentage of SpO2	1.6 Percentage of SpO2	1.7 Percentage of SpO2

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kara Cassady

Medline Industries, Inc

Phone: 847-643-3809

Email: kcassady@medline.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER