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Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and skin pigmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MightySat | Experimental | All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MightySat | Device | Noninvasive pulse oximeter |
|
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy of the MightySat Pulse Oximeter | The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SaO2_i )^2 ))/n. | 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 | MightySat | All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s). MightySat: Noninvasive pulse oximeter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MightySat | All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s). MightySat: Noninvasive pulse oximeter |
| 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 | SpO2 Accuracy of the MightySat Pulse Oximeter | The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SaO2_i )^2 ))/n. | 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 | MightySat | All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s). MightySat: Noninvasive pulse oximeter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Lab Operations | 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 | Sep 28, 2021 | Aug 27, 2024 | Prot_SAP_001.pdf |
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| Study Staff Decision |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 0 |
| 39 |
| 0 |
| 39 |
| 13 |
| 39 |
| Dizziness/Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Arterial line (healing) | Surgical and medical procedures | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Abnormal ECG | Cardiac disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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