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The data from the study showed good trending of Delta ORi and Delta PaO2. The study was stopped before full enrollment as a newer version of ORi was developed.
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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.) 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 blood samples from a laboratory analyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00014 | Device | Noninvasive pulse oximeter sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity, Sensitivity, and Concordance for the ORi Measurement System as Compared to PaO2 | This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples. | 1-5 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 the 33 enrolled participants, 16 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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Specificity, Sensitivity, and Concordance for the ORi Measurement System as Compared to PaO2 | This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples. | Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 22 completed subjects. This study was not able to meet this target and therefore the specificity, sensitivity and concordance for Masimo's ORi measurement system could not be defined (primary outcome measure). | Posted | 1-5 hours per subject |
|
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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 949-297-7000 | studies@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 | May 14, 2018 | Aug 12, 2021 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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