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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 at various times during the study. The subject will then be returned to breathing room air.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00031 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00031 | Device | Noninvasive pulse oximeter sensor |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion | 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 during non-motion. | 1-5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion | 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 during motion. | 1-5 hours |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00031 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00031 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion. |
| 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 | One subject was withdrawn prior to completing study procedures. |
| 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 by Arms Calculation During Non-motion | 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 during non-motion. | Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure. | Posted | Number | % of oxygen saturated hemoglobin | 1-5 hours |
|
1 week
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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 | INVSENSOR00031 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scraped skin | Injury, poisoning and procedural complications | Non-systematic Assessment | Subjects skin was scraped with scissors, no visual abrasion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | Masimo | 1-949-297-7100 | 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 | Dec 4, 2018 | Jun 12, 2019 | Prot_SAP_000.pdf |
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| Count of Participants |
| Participants |
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| Sex: Female, Male | One subject was withdrawn prior to completing study procedures. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | One subject was withdrawn prior to completion of study procedures. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion | 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 during motion. | Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure. | Posted | Number | % of oxygen saturated hemoglobin | 1-5 hours |
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| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
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