Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00039 (NCT NCT04112784)

NCT ID: NCT04112784

Last Updated: 2022-10-06

Results Overview

Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (ARMS) value.

• Recruitment status: COMPLETED
• Target enrollment: 38 participants
• Primary outcome timeframe: 1-5 hours
• Results posted on: 2022-10-06

Participant Flow

Participant milestones

Measure	INVSENSOR00039 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. INVSENSOR00039: Noninvasive pulse oximeter sensor
Overall Study STARTED	38
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	INVSENSOR00039 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. INVSENSOR00039: Noninvasive pulse oximeter sensor
Overall Study Did Not Proceed Due to Time Constraints	9
Overall Study Screen Failures	4

Baseline Characteristics

Desaturation Validation of INVSENSOR00039

Baseline characteristics by cohort

Measure	INVSENSOR00039 n=25 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. INVSENSOR00039: Noninvasive pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 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	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (ARMS) value.

Outcome measures

Measure	INVSENSOR00039 n=25 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. INVSENSOR00039: Noninvasive pulse oximeter sensor
Oxygen Saturation (SpO2) Accuracy of Sensor	1.0 percentage of oxygen saturation

Adverse Events

INVSENSOR00039

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 Corporation

Phone: 949-297-7000

Email: aalghazi@masimo.com

Results disclosure agreements

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