Trial Outcomes & Findings for INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study (NCT NCT03897179)

Last Updated: 2020-03-27

Results Overview

Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 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

Target enrollment

27 participants

Primary outcome timeframe

1-5 hours

Results posted on

2020-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00032 and INVSENSOR00033 Test Group All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
Overall Study STARTED	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00032 and INVSENSOR00033 Test Group All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
Overall Study Withdrawal by Subject	1

Baseline Characteristics

INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00032 and INVSENSOR00033 Test Group n=27 Participants All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Outcome measures

Outcome measures
Measure	INVSENSOR00032 and INVSENSOR00033 Test Group n=26 Participants All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device
RRp Arms of Sensor Accuracy	2.1 respiration per minute (RPM)

Adverse Events

INVSENSOR00032 and INVSENSOR00033 Test Group

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place