Raydiant Oximetry, Inc.
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% pos…
Inclusion Criteria: 1. Willing and capable of providing informed consent. 2. Age \> 18 years. 3. Gestational age \> 36 weeks. 4. Singleton pregnancy. 5. Vertex presentation, 6. In latent or active labor, 7. Category I or II tracings, 8. Epidural anesthesia, and 9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower. Exclusion Criteria: 1. Age \< 18 years. 2. Gestational age \< 36 weeks 3. Multiple gestation 4. Nonvertex fetal presentation 5. Suspected vasa previa 6. Category III CTG tracing 7. Fetal anomalies and/or chromosomal disorders 8. Chorioamnionitis 9…
Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.
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