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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORi sensor | Experimental | All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORi sensor | Device | Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Less than 30 mins |
| 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. | Less than 30 mins |
| 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. | Less than 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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, 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 | 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. | 1 subject was excluded as investigator reported unreliable data. | Posted | Number | percentage of true positives | Less than 30 mins |
|
Less than 30 min
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Masimo Corporation | 949-297-7000 | clincalresearchdept@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 | Jan 22, 2018 | Aug 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| 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 specificity is calculated to evaluate changes in ORi relative to the changes in PaO2. | 1 subject was excluded as investigator reported unreliable data. | Posted | Number | percentage of true negatives | Less than 30 mins |
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| 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. | 1 subject was excluded as investigator reported unreliable data. | Posted | Number | percentage of accuracy | Less than 30 minutes |
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