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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Monitoring
• Intervention / Treatment: Device: ATLASense RAPHAEL 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATLASense RAPHAEL monitoring; All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery.	Device: ATLASense RAPHAEL PolyMonitor; All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Trevor Szymanski, MD, MBA, Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: temperature; blood pressure; heart rate; respiratory rate
• Other Study ID Numbers: 14139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No