Respiration Rate Monitoring During Transitions

Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation

The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.

Inclusion Criteria:

• Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
• American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
• Body mass index (BMI) ≤30 kg/m2.
• Subject is willing and able to provide written consent.

Exclusion Criteria:

• Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
• Female subjects who are currently lactating and breastfeeding.
• Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
• Subject has an abnormality that may prevent proper application of the device/sensors.
• Subject is in atrial fibrillation.
• Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
• Subject has an implanted pacemaker.
• Subjects with non-sinus rhythm, frequent premature ventricular complexes (> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
• Subjects with artificial finger nails.