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Terminated due to lack of enrollment at target sites
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This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Subjects ages birth to 30 days | ||
| Infants | Subjects aged >30 days to 2 years | ||
| Adults | Subjects aged 18 years of age or older |
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| Measure | Description | Time Frame |
|---|---|---|
| This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG. | unlimited |
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Inclusion Criteria:
Exclusion Criteria:
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All populations (neonatal, pediatrics, and adults).
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| Name | Affiliation | Role |
|---|---|---|
| Jean D Sesing | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Tampa | Florida | 33614 | United States |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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