Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Oxygen Reserve Index (ORI) is a parameter that provides information on arterial partial pressure of oxygen (PaO2). In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from a laboratory analyzer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects are enrolled into the test group and all subjects received the Noninvasive Oxygen Reserve Index - RD Lite Sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Reserve Index - RD Lite Sensors | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of ORI to Detect Drops in Oxygenation | 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). | 1-5 hours per subject |
| Sensitivity of ORI to Detect Drops in Oxygenation | A 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). | 1-5 hours |
| Concordance of ORI to Detect Drops in Oxygenation | A 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%). | 1-5 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Specificity of ORI to Detect Drops in Oxygenation | 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). | Posted | Number | percentage of true negative | 1-5 hours per subject |
|
|
1 to 5 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial line site sensitivity | Surgical and medical procedures | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 949-297-7000 | studies@masimo.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2017 | Jun 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2017 | Jun 4, 2020 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Sensitivity of ORI to Detect Drops in Oxygenation | A 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). | Posted | Number | percentage of true positives | 1-5 hours |
|
|
|
| Primary | Concordance of ORI to Detect Drops in Oxygenation | A 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%). | Posted | Number | percentage of accuracy | 1-5 hours |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| PaO2 Threshold: 140 mmHg |
|
| PaO2 Threshold: 150 mmHg |
|
| PaO2 Threshold: 160 mmHg |
|
| PaO2 Threshold: 170 mmHg |
|
| PaO2 Threshold: 180 mmHg |
|
| PaO2 Threshold: 190 mmHg |
|
| Title | Measurements |
|---|---|
|
| PaO2 Threshold: 140 mmHg |
|
| PaO2 Threshold: 150 mmHg |
|
| PaO2 Threshold: 160 mmHg |
|
| PaO2 Threshold: 170 mmHg |
|
| PaO2 Threshold: 180 mmHg |
|
| PaO2 Threshold: 190 mmHg |
|