Trial Outcomes & Findings for Oxygen Reserve Index (ORi) Validation of INVSENSOR00025 (NCT NCT03628898)
NCT ID: NCT03628898
Last Updated: 2021-08-27
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.
COMPLETED
47 participants
1-5 hours per subject
2021-08-27
Participant Flow
Of of the 47 enrolled participants, 27 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
| Measure |
Test Subject
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Test Subject
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Overall Study
Device deficiency
|
1
|
Baseline Characteristics
Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
Baseline characteristics by cohort
| Measure |
Test Subject
n=26 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Age, Customized
< 18 years old
|
0 Participants
n=93 Participants
|
|
Age, Customized
18 to 50 years old
|
26 Participants
n=93 Participants
|
|
Age, Customized
> 50 years old
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1-5 hours per subjectORi 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.
Outcome measures
| Measure |
Test Subject
n=26 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 110 mmHg
|
94.82 percentage of true negatives
|
|
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 150 mmHg
|
90.69 percentage of true negatives
|
|
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 190 mmHg
|
100 percentage of true negatives
|
PRIMARY outcome
Timeframe: 1-5 hours per subjectORi 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.
Outcome measures
| Measure |
Test Subject
n=26 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 110 mmHg
|
100 percentage of true positives
|
|
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 150 mmHg
|
96.82 percentage of true positives
|
|
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 190 mmHg
|
93.37 percentage of true positives
|
PRIMARY outcome
Timeframe: 1-5 hours per subjectORi 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.
Outcome measures
| Measure |
Test Subject
n=26 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor
INVSENSOR00025: Noninvasive pulse oximeter sensor
|
|---|---|
|
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 110 mmHg
|
94.22 percentage of accuracy
|
|
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 150 mmHg
|
94.34 percentage of accuracy
|
|
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
PaO2 Threshold: 190 mmHg
|
93.44 percentage of accuracy
|
Adverse Events
Test Subject
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place