Trial Outcomes & Findings for Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029 (NCT NCT04079842)

Last Updated: 2022-10-19

Results Overview

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.

Recruitment status

COMPLETED

Target enrollment

29 participants

Primary outcome timeframe

1-5 hours per subject

Results posted on

2022-10-19

Participant Flow

Of of the 54 enrolled participants, 29 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.

Participant milestones

Participant milestones
Measure	INVSENSOR00029 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Overall Study STARTED	29
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00029 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Overall Study Request of subject	2
Overall Study Unable to draw Arterial samples	1

Baseline Characteristics

Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00029 n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Age, Customized <18 years old	0 Participants n=5 Participants
Age, Customized 18 to 50 years old	26 Participants n=5 Participants
Age, Customized >50 years old	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=5 Participants
Race/Ethnicity, Customized Black/Dark Skinned/African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours per subject

Outcome measures

Outcome measures
Measure	INVSENSOR00029 n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values PaO2 Threshold: 110 mmHg	99.4 percentage of accuracy
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values PaO2 Threshold: 150 mmHg	89.74 percentage of accuracy
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values PaO2 Threshold: 190 mmHg	89.86 percentage of accuracy

PRIMARY outcome

Timeframe: 1 to 5 hours per subject

Outcome measures

Outcome measures
Measure	INVSENSOR00029 n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 110 mmHg	99.39 percentage of true negatives
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 150 mmHg	83.48 percentage of true negatives
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 190 mmHg	NA percentage of true negatives Changes in ORi (DeltaORi) are being compared to changes in PaO2 (DeltaPaO2 )in the reference PaO2 range of 100-200 mmHg. For the PaO2 threshold of 190 mmHg, reference PaO2 samples are outside the level of detection and thus data is not available to compute specificity.

PRIMARY outcome

Timeframe: 1 to 5 hours per subject

Outcome measures

Outcome measures
Measure	INVSENSOR00029 n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 110 mmHg	NA percentage of true positives Changes in ORi (DeltaORi) are being compared to changes in PaO2 (DeltaPaO2 )in the reference PaO2 range of 100-200 mmHg. For the PaO2 threshold of 110 mmHg, reference PaO2 samples are outside the level of detection and thus data is not available to compute sensitivity.
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 150 mmHg	94.30 percentage of true positives
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. PaO2 Threshold: 190 mmHg	90.18 percentage of true positives

Adverse Events

INVSENSOR00029

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place