NCT05291949

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

Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraoperative Monitoring

Interventions

Type	Name	Description
DEVICE	ATLASense RAPHAEL PolyMonitor	All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2022-03-23
• Last updated: 2023-08-16
• Results posted: 2023-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study