Trial Outcomes & Findings for SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions (NCT NCT05264116)

NCT ID: NCT05264116

Last Updated: 2025-05-20

Results Overview

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 1-2 hours
• Results posted on: 2025-05-20

Participant Flow

Participant milestones

Measure	Healthy Adult Participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions

Baseline characteristics by cohort

Measure	Healthy Adult Participants n=12 Participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiethnic	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Outcome measures

Measure	Device 1 n=12 Participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. Device 1 consists of non-woven butterfly style tape. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors.	Device 2 n=12 Participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors. Device 2 consists of a woven style tape. STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS: Reprocessed noninvasive pulse oximeter sensors.
Accuracy of Sensor by Arms Calculation Under Motion Conditions	2.80 Root Mean Square Error (%)	2.66 Root Mean Square Error (%)

Adverse Events

Device 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Device 2

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

Monique Ketcher

Stryker Sustainability Solutions

Phone: 602-354-0917

Email: monique.ketcher@stryker.com

Results disclosure agreements

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