Trial Outcomes & Findings for Oxygen Reserve Index Validation for RD Lite Sensors (NCT NCT03128892)
NCT ID: NCT03128892
Last Updated: 2021-03-01
Results Overview
A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Specificity, as measured in this outcome, is the probability of ORI not dropping when there is no drop in blood oxygen levels (desaturation).
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
1-5 hours per subject
Results posted on
2021-03-01
Participant Flow
Participant milestones
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Oxygen Reserve Index Validation for RD Lite Sensors
Baseline characteristics by cohort
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
n=31 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-5 hours per subjectA measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Specificity, as measured in this outcome, is the probability of ORI not dropping when there is no drop in blood oxygen levels (desaturation).
Outcome measures
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
n=31 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 110 mmHg
|
98.50 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 120 mmHg
|
96.68 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 130 mmHg
|
98.89 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 140 mmHg
|
96.95 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 150 mmHg
|
97.67 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 160 mmHg
|
94.75 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 170 mmHg
|
93.60 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 180 mmHg
|
96.23 percentage of true negative
|
|
Specificity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 190 mmHg
|
95.82 percentage of true negative
|
PRIMARY outcome
Timeframe: 1-5 hoursA measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Sensitivity, as measured in this outcome, is the probability of ORI dropping when there is a drop in blood oxygenation levels (desaturation).
Outcome measures
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
n=31 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 190 mmHg
|
88.27 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 110 mmHg
|
84.96 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 120 mmHg
|
89.85 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 130 mmHg
|
85.51 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 140 mmHg
|
89.47 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 150 mmHg
|
86.17 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 160 mmHg
|
87.13 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 170 mmHg
|
83.96 percentage of true positives
|
|
Sensitivity of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 180 mmHg
|
85.40 percentage of true positives
|
PRIMARY outcome
Timeframe: 1-5 hoursA measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Concordance, as measured in this outcome, is the probability of ORI to respond accurately to changes (or lack of thereof) in underlying blood oxygenation levels. It is computed as a ratio of true classifications (true positives and true negatives) to the sample size. An ideal detector will have a concordance value of 1 (or 100%).
Outcome measures
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
n=31 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 110 mmHg
|
88.83 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 120 mmHg
|
92.46 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 130 mmHg
|
91.47 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 140 mmHg
|
93.33 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 150 mmHg
|
93.00 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 160 mmHg
|
92.16 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 170 mmHg
|
90.80 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 180 mmHg
|
93.78 percentage of accuracy
|
|
Concordance of ORI to Detect Drops in Oxygenation
PaO2 Threshold: 190 mmHg
|
94.39 percentage of accuracy
|
Adverse Events
Oxygen Reserve Index (ORi) - RD Lite Sensors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxygen Reserve Index (ORi) - RD Lite Sensors
n=34 participants at risk
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors.
|
|---|---|
|
Surgical and medical procedures
Arterial line site sensitivity
|
2.9%
1/34 • 1 to 5 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place