Hyperoxia
Conditions
Brief summary
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.
Interventions
DEVICEORi sensor
Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * ASA physical status III or IV * Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia
Exclusion criteria
* Age less than 18 years * Adults unable to give primary consent * Pregnancy * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | Less than 30 mins | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2. |
| Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | Less than 30 mins | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2. |
| Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | Less than 30 minutes | ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ORi Sensor All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure
ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Equipment malfunction | 1 |
Baseline characteristics
| Characteristic | ORi Sensor | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 18 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 1 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 minutes
Population: 1 subject was excluded as investigator reported unreliable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORi Sensor | Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 95.05 percentage of accuracy |
Primary
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 mins
Population: 1 subject was excluded as investigator reported unreliable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORi Sensor | Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 100 percentage of true positives |
Primary
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 mins
Population: 1 subject was excluded as investigator reported unreliable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORi Sensor | Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 94.38 percentage of true negatives |