Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors

Not Applicable

Completed

Brief Summary: The aim of this observational comparison study is to compare the HR and respiratory RR of intraoperative surgical patients simultaneously recorded by standard intraoperative monitors and the ATLASense RAPHAEL PolyMonitor. A second aim is to determine the extent of data loss and data gap duration, and validate the PolyMonitor alert system for tachycardia and bradycardia. Additional parameters of non-invasive blood pressure (NIBP) and body temperature will also be compared between the PolyMonitor and standard intraoperative monitors. Finally, this study will provide insight into the logistics of intraoperative use of the PolyMonitor.

Detailed Description: The ATLASense Raphael PolyMonitor will be placed on the patient's left chest mid sternal line in the operating room. Traditional physiologic monitors described above will also be placed on the patient in the operating room. Data will be collected via the ATLASense system and through the traditional operating room monitors, and this data will be time matched through synchronization of the monitors post hoc. The time matched data pairs will undergo statistical analysis post hoc. It is anticipated that this study will validate the intraoperative HR and RR measured through the ATLASense Raphael PolyMonitor, providing adequate data points for statistical analysis with 95% limits of agreement, bias, and data loss/gaps. Success is also the logistical lessons learned for using this monitor in the intraoperative setting.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Pregnant adult female
Thoracic surgery
Left lateral decubitus positioning required during procedure
Surgery involving the left flank, or requiring surgical field involving the left flank
Surgery involving the left chest, or requiring surgical field involving the left chest
Allergy to adhesives
Open wound, rash, or sore involving the left chest
Presence of cardiac defibrillator, or pacemaker

Arm && Interventions

Group	Intervention	Description
ATLASense RAPHAEL monitoring	ATLASense RAPHAEL PolyMonitor	All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery.

Primary Outcome Measures

Name	Time	Method
Respiratory Rate (RR)	Entire duration of surgery	Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Heart Rate (HR)	Entire duration of surgery	Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (Mean Arterial Pressure)	Entire duration of surgery	Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Gaps in Data Collection	Entire duration of surgery	Length and frequency of gaps in data collection when the ATLASense RAPHAEL PolyMonitor or standard intraoperative monitors did not collect data.
Core Body Temperature	Entire duration of surgery	Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor