N/A N=70 Other

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

Intraoperative Monitoring

Bottom Line

View on ClinicalTrials.gov: NCT05291949 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Heart Rate (HR) — 0.922 Spearman Correlation Coefficient

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ATLASense RAPHAEL PolyMonitor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate (HR)	0.922	—
PRIMARY Respiratory Rate (RR)	0.714	—
SECONDARY Gaps in Data Collection	15.5	—
SECONDARY Blood Pressure (Mean Arterial Pressure)	0.065	—
SECONDARY Core Body Temperature	0.158	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05291949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.