Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05291949
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2022-03-14
Brief Title:
Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATLASense
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
Detailed Description:
The ATLASense Raphael PolyMonitor will be placed on the patients 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 lossgaps Success is also the logistical lessons learned for using this monitor in the intraoperative setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None