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This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor.
Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00040 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00040 | Device | Noninvasive wearable health monitoring device |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation (SpO2) Accuracy of INVSENSOR00040 | SpO2 performance will be determined by calculating the arithmetic root square mean (ARMS) value through the comparison of the noninvasive SpO2 measurement obtained from INVSENSOR00040 to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The desaturation range over which the accuracy is performed is 70-100%. | 1-5 hours |
| Pulse Rate (PR) Accuracy of INVSENSOR00040 | Pulse Rate (PR) performance will be determined by calculating the ARMS value through the comparison of the PR values obtained from INVSENSOR00040 to the heart rate (HR) values obtained from a reference standard of care EKG monitor. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The PR/HR range over which the accuracy is calculated is determined by convenience sampling in a generally healthy population undergoing a desaturation procedure. | 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 | INVSENSOR00040 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00040 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device |
| 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 | Oxygen Saturation (SpO2) Accuracy of INVSENSOR00040 | SpO2 performance will be determined by calculating the arithmetic root square mean (ARMS) value through the comparison of the noninvasive SpO2 measurement obtained from INVSENSOR00040 to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The desaturation range over which the accuracy is performed is 70-100%. | Data from 13 subjects was excluded due to desaturation procedural error. Data from 1 subject was excluded due to missing data and evidence of noise interference that did not allow for the comparison of the dataset. Data from 1 subject was excluded because the subject complained of discomfort at the early part of the desaturation procedure and therefore was unable to desaturate to below 90% SaO2. | Posted | Number | % of oxygen saturated hemoglobin | 1-5 hours |
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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 | INVSENSOR00040 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unilateral temporal headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo | 949-297-7437 | aalghazi@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 | Mar 14, 2023 | Dec 18, 2023 | Prot_SAP_000.pdf |
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| Subject's decision |
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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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device |
|
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| Primary | Pulse Rate (PR) Accuracy of INVSENSOR00040 | Pulse Rate (PR) performance will be determined by calculating the ARMS value through the comparison of the PR values obtained from INVSENSOR00040 to the heart rate (HR) values obtained from a reference standard of care EKG monitor. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The PR/HR range over which the accuracy is calculated is determined by convenience sampling in a generally healthy population undergoing a desaturation procedure. | Data from 13 subjects excluded due to desaturation procedural error. Data from 1 subject excluded due to missing data & evidence of noise interference that did not allow for the comparison of the dataset. Data from 1 subject excluded because subject complained of discomfort at early part of desaturation procedure, therefore was unable to desaturate to below 90% SaO2. Data from 2 subjects excluded for no valid PR & ECG HR pair, because ECG HR data was not recorded in the server properly. | Posted | Number | beats per minute | 1-5 hours |
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| 0 |
| 46 |
| 0 |
| 46 |
| 4 |
| 46 |
| Lightheadedness | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Swelling/Tenderness at arterial line site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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