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ORi is a unitless index 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. In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00029 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00029 | Device | Noninvasive pulse oximeter sensor |
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| Measure | Description | Time Frame |
|---|---|---|
| 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, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | 1-5 hours per subject |
| 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, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | 1 to 5 hours per subject |
| 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, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | 1 to 5 hours per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | 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, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | Posted | Number | percentage of accuracy | 1-5 hours per subject |
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1 to 5 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo Corporation | 949-297-7000 | aalghazi@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2020 | Aug 9, 2022 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | Posted | Number | percentage of true negatives | 1 to 5 hours per subject |
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| 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, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2. | Posted | Number | percentage of true positives | 1 to 5 hours per subject |
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| 26 |
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| 26 |
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| Title | Measurements |
|---|---|
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| PaO2 Threshold: 190 mmHg |
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