Trial Outcomes & Findings for Clinical Validation for SpO2 Function of Masimo INVSENSOR00069 (NCT NCT06120777)

NCT ID: NCT06120777

Last Updated: 2024-11-27

Results Overview

The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.

Recruitment status

COMPLETED

Study phase

Target enrollment

89 participants

Primary outcome timeframe

1-3 hours

Results posted on

2024-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Masimo INVSENSOR00069 All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter
Overall Study STARTED	89
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo INVSENSOR00069 n=36 Participants All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-3 hours

Population: 10 subjects not analyzed due to incorrect sensor 3 subjects not analyzed due to not desaturating to the lowest bin (70-80%)

Outcome measures

Outcome measures
Measure	Masimo INVSENSOR00069 n=23 Participants All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter
SpO2 Accuracy of Masimo INVSENSOR00069	1.72 % of oxygen saturated hemoglobin

Adverse Events

Masimo INVSENSOR00069

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Masimo INVSENSOR00069 n=86 participants at risk All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. INVSENSOR00069: Noninvasive pulse oximeter
Nervous system disorders Dizziness/Lightheadedness	5.8% 5/86 • 1-3 hours
Gastrointestinal disorders Nausea	1.2% 1/86 • 1-3 hours
Cardiac disorders Hypotension	1.2% 1/86 • 1-3 hours
Cardiac disorders Increased heart rate	1.2% 1/86 • 1-3 hours
Nervous system disorders Numbness	1.2% 1/86 • 1-3 hours

Additional Information

Ahmed Alghazi

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place