Trial Outcomes & Findings for INVSENSOR00013 Respiratory Rate Clinical Performance Study (NCT NCT03440619)

NCT ID: NCT03440619

Last Updated: 2019-04-23

Results Overview

Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 1-5 hours
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	INVSENSOR00013 Sensor All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

INVSENSOR00013 Respiratory Rate Clinical Performance Study

Baseline characteristics by cohort

Measure	INVSENSOR00013 Sensor n=28 Participants All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized African American	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

Outcome measures

Measure	INVSENSOR00013 Sensor n=28 Participants All subjects are enrolled into the test group and received one INVSENSOR00013 sensor.
RRp Arms of Sensor Accuracy	1.2 respiration per minute (RPM)

Adverse Events

INVSENSOR00013 Sensor

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

Ahmed Alghazi

Masimo

Phone: 949-297-7000

Email: studies@masimo.com

Results disclosure agreements

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