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

NCT05291949 | Completed Results FDA Device

• 1 other identifier: 14139
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Monitoring

Keywords

heart rate; respiratory rate; blood pressure; temperature

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Gaps in Data Collection

  Entire duration of surgery

• Blood Pressure (Mean Arterial Pressure)

  Entire duration of surgery

• Core Body Temperature

  Entire duration of surgery

Study Arms (1)

ATLASense RAPHAEL monitoring

EXPERIMENTAL

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

Device: ATLASense RAPHAEL PolyMonitor

Interventions

ATLASense RAPHAEL PolyMonitor DEVICE

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

ATLASense RAPHAEL monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Results Point of Contact

• Title: Director of Research, Department of Anesthesiology
• Organization: Henry Ford Health

knowak2@hfhs.org

313-771-7128

Study Officials

• Trevor Szymanski, MD, MBA

  Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Anesthesiologist

Model Details: Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: October 18, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Locations

US (1)