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This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00032 and INVSENSOR00033 test group | Experimental | All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00032 and INVSENSOR00033 | Device | Investigational pulse oximeter device |
|
| Measure | Description | Time Frame |
|---|---|---|
| RRp Arms of Sensor Accuracy | Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value. | 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 | INVSENSOR00032 and INVSENSOR00033 Test Group | All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00032 and INVSENSOR00033 Test Group | All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | RRp Arms of Sensor Accuracy | Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value. | Posted | Number | respiration per minute (RPM) | 1-5 hours |
|
Adverse event data was collected over the course of the study (13 days).
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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 | INVSENSOR00032 and INVSENSOR00033 Test Group | All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo | 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 | Dec 18, 2018 | Mar 13, 2020 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
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