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Trial Outcomes & Findings for SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor (NCT NCT05141500)

NCT ID: NCT05141500

Last Updated: 2022-12-21

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. 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

2022-12-21

Participant Flow

Participant milestones

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 oximeters * Masimo pulse oximeter sensors, 1859 \& 2329 * Nellcor pulse oximeter sensors, MAX-A \& MAX-N
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 Pulse Oximeter Sensor

Baseline characteristics by cohort

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 oximeters * Masimo pulse oximeter sensors, 1859 \& 2329 * Nellcor pulse oximeter sensors, MAX-A \& MAX-N
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
4 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
4 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 non-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

Outcome measures
Measure
Reprocessed MAX-N
n=12 Participants
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Reprocessed MAX-A
n=12 Participants
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Reprocessed 1859
n=12 Participants
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Reprocessed 2329
n=12 Participants
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Accuracy of Sensor by Arms Calculation
1.62 Root Mean Square Error (%)
1.56 Root Mean Square Error (%)
1.48 Root Mean Square Error (%)
1.72 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

Monique Ketcher

Stryker Sustainability Solutions

Phone: 602-354-0917

Results disclosure agreements

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