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

Intraoperative Monitoring Clinical Trial

— ATLASense  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291949
• Other study ID #: 14139
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: January 17, 2022

Study information

• Verified date: July 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Monitoring

Intervention

Device:
• ATLASense RAPHAEL PolyMonitor
All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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