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The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newborn | A variety of subjects will be targeted for inclusion representing differing stages of development and environments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System | Device | The Nellcor™ N-600x Pulse Oximetry System with N-600X Pulse Oximeter and Nellcor™ Sensors and Cables with OxiMax technology is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and PR. The N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare time to stable signal of heart rate (HR) estimation between two pulse oximeters (PO). | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. | |
| To compare overall accuracy of heart rate (HR) estimation between two pulse oximeters (PO) as compared to gold standard electrocardiography (ECG). | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate instances of false bradycardia. | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. | |
| To evaluate instances of false bradycardia requiring emergency medical treatment. | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 120 newborns will be selected for this study. A variety of subjects will be targeted for inclusion representing differing stages of development and environments
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai | Los Angeles | California | 90048 | United States | ||
| Washington University in St. Louis |
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|
| LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter | Device | The Masimo Rad-97™ and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin, PR, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or acoustic respiratory rate (RRa). The Masimo Rad-97™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97™ and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97™ and accessories for functional oxygen saturation of arterial hemoglobin and PR to multi-parameter devices for the display on those devices. |
|
| 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor | Device | Market-released ECG monitoring system |
|
| To evaluate variability in PR between the two PO sensors | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. |
| To compare the number of repositions and replacements required for the two PO sensors during monitoring. | Subject participation is expected to last a minimum of 5 minutes and a maximum of 12 hours. |
| St Louis |
| Missouri |
| 63130 |
| United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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