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In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00026 | Device | Noninvasive pulse oximeter sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation | Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value 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 Error 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 |
Protocol enrollment number includes screen failures and subjects that did not proceed due to time constraints
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects whose hemoglobin levels did not meet predefined study requirements were not included in the final data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
| 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 | Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation | Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value 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 Error value. | Posted | Number | g/dL | 1-5 hours |
|
5 months
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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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling due to IV catheter site infiltration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | Masimo | 9492977000 | 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 | Feb 26, 2019 | Apr 17, 2019 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 8 |
| 93 |
| Vasovagal episode during arterial line placement | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Numbness secondary to local anesthetic infiltration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Bruising and swelling at arterial site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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