CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
ATLASense RAPHAEL PolyMonitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05291949
NCT05291949N/ACompleted
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Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors

Henry Ford Health System·interventional·Posted Mar 23, 2022·Updated Aug 16, 2023

In Brief

A clinical study evaluating ATLASense RAPHAEL PolyMonitor for Intraoperative Monitoring. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntraoperative Monitoring
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 23, 2022
Enrollment StartOct 18, 2021
Primary CompletionJan 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.3 years ago

Interventions

ATLASense RAPHAEL PolyMonitordevice

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