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
ORi is a unitless index that could help clinicians with their assessments or 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 INVSENSOR00029 sensor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00029 | Device | Noninvasive pulse oximeter sensor |
|
| 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. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | 1-5 hours |
| Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | 1-5 hours |
| Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values | ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | 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 |
Of the 57 enrolled participants, 30 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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test Subject | 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 |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test Subject | 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 |
|
| 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 | Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | Posted | Number | percentage of true positives | 1-5 hours |
|
|
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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensitivity at arterial line site | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2019 | Aug 31, 2021 | Prot_SAP_000.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 |
|
|
| Primary | Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | Posted | Number | percentage of true negatives | 1-5 hours |
|
|
|
| Primary | Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values | ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg. | Posted | Number | percentage of accuracy | 1-5 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| Vasovagal | Surgical and medical procedures | Non-systematic Assessment |
|
Not provided
Not provided
Not provided