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
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion.After completing the desaturation, the gas mixture will be returned to room air concentrations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00012 | Experimental | All subjects consented are enrolled into the test group and will receive the INVSENSOR00012. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00012 | Device | Noninvasive pulse oximeter sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SpO2) Accuracy of Sensor | Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value. | 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 39 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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00012 | All subjects consented are enrolled into the test group and will receive the INVSENSOR00012. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00012 | All subjects consented are enrolled into the test group and will receive the INVSENSOR00012. |
| 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 | Oxygen Saturation (SpO2) Accuracy of Sensor | Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value. | Posted | Number | % of oxygen saturated hemoglobin | 1-5 hours | blood samples | blood samples |
|
|
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 | INVSENSOR00012 | All subjects consented are enrolled into the test group and will receive the INVSENSOR00012. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | (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 | Dec 11, 2017 | Mar 5, 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 |
|
|
| blood samples |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
Not provided
Not provided
Not provided