Trial Outcomes & Findings for Feasibility and Performance Evaluation for INVSENSOR00024 (NCT NCT03570255)

Last Updated: 2020-02-20

Results Overview

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 root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, 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 RMS Error value.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

up to 8 hours

Results posted on

2020-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	RD SET Neo SpO2 All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility and Performance Evaluation for INVSENSOR00024

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RD SET Neo SpO2 n=28 Participants All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
Age, Categorical <=18 years	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 hours

Population: Subject 7 \& 11: Protocol deviation Subject 19 \& 26: Outlier data points Subject 5: Removed per ISO standard for SpO2 equal to 100.

Outcome measures

Outcome measures
Measure	RD SET Neo SpO2 n=23 Participants All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation	2.1 percent of oxygen saturated hemoglobin

Adverse Events

RD SET Neo SpO2

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

Vikram Ramakanth

Masimo

Phone: 949-297-7416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60