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

Henry Ford Health

Status: Completed

Conditions: Intraoperative Monitoring

Treatments: Device: ATLASense RAPHAEL PolyMonitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05291949

14139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Adult males or females (above the age of 18)
• Scheduled to undergo general anesthesia during elective surgery

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

ATLASense RAPHAEL monitoring

Experimental group

Description:

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

Treatment:

Device: ATLASense RAPHAEL PolyMonitor