Table 1. Study eligibility criteria and definitions.
Eligibility criteria | |
---|---|
Inclusion criteria | • Male or female neonate, corrected age of <28 days
• Willingness and ability of neonate’s caregiver to provide informed consent and to be available for follow-up for the planned duration of the study |
Exclusion criteria | • Receiving mechanical ventilation or continuous positive airway pressure
• Skin abnormalities in the nasopharynx and/or oropharynx • Contraindication to the application of skin sensors • Known arrhythmia • Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the neonate’s health |
Study definitions | |
Epoch | A 60-second period of time |
Heartbeat | One pulsation of the heart, including one complete contraction and dilatation |
Heart rate (HR) | Number of heart beats within an epoch |
Breath | One cycle of inhalation and exhalation |
Breath duration | Length of time from the start to the end of a single breath |
Respiratory rate (RR) | Number of breaths initiated within an epoch |
Pulse oximetry signal
quality index (PO-SQI) |
Automated indicator of signal quality from the plethysmographic recording. |
CO 2-SQI | Algorithm-defined indicator of signal quality from the capnography channel |
Accuracy | The closeness a measured value is from the true value |
Repeatability | The closeness of the results of successive measurements of the same measure |
Agreement (between
measures) |
The consistency between two sets of measurements |
Accuracy Threshold | A pre-specified value used to determine if a set of measurements has achieved a sufficient accuracy when
compared with a reference value |
Precision | The closeness of measurements to each other |