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Trial Outcomes & Findings for SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions (NCT NCT06149416)

NCT ID: NCT06149416

Last Updated: 2025-06-06

Results Overview

The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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

11 participants

Primary outcome timeframe

1 - 5 hours

Results posted on

2025-06-06

Participant Flow

Participant milestones

Participant milestones
Measure
Healthy Adult Participants
Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors Experimental Masimo RD SET SpO2 Adhesive Sensors: Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)
Overall Study
STARTED
11
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Adult Participants
n=11 Participants
Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors Experimental Masimo RD SET SpO2 Adhesive Sensors: Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Multiethnic
2 Participants
n=5 Participants
Region of Enrollment
United States
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 - 5 hours

The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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

Outcome measures
Measure
Masimo RD SET SpO2 Adhesive Sensors: Adult (4000 Adt), Adult & Neonate (4003)
n=11 Participants
Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]
Device 1 4000-Adt Accuracy
1.84 Root Mean Square Error (%)
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]
Device 2 4003-Neo Accuracy
2.33 Root Mean Square Error (%)

Adverse Events

Healthy Adult 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

Senior Principal Regulatory Affairs

Stryker Sustainability Solutions

Phone: 5602-410-0204

Results disclosure agreements

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