Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
120 participants
OBSERVATIONAL
2024-09-10
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newborn
A variety of subjects will be targeted for inclusion representing differing stages of development and environments
OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System
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.
LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter
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
Market-released ECG monitoring system
Interventions
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OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System
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.
LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter
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
Market-released ECG monitoring system
Eligibility Criteria
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Inclusion Criteria
* Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
* Subject is ≥ 29 weeks gestational age.
* Subject can accommodate multiple sensors.
Exclusion Criteria
* Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
* Currently participating in any other study expected to confound study results in the opinion of the investigator.
29 Weeks
ALL
Yes
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai
Los Angeles, California, United States
Washington University in St. Louis
St Louis, Missouri, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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MDT24005PROLD
Identifier Type: -
Identifier Source: org_study_id
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