Trial Outcomes & Findings for Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors (NCT NCT05291949)

NCT ID: NCT05291949

Last Updated: 2023-08-16

Results Overview

Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

Entire duration of surgery

Results posted on

2023-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	ATLASense RAPHAEL Monitoring All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Overall Study STARTED	70
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATLASense RAPHAEL Monitoring n=70 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=39 Participants
Age, Categorical >=65 years	18 Participants n=39 Participants
Age, Continuous	60 years n=39 Participants
Sex: Female, Male Female	29 Participants n=39 Participants
Sex: Female, Male Male	41 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	16 Participants n=39 Participants
Race (NIH/OMB) White	48 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=39 Participants
Region of Enrollment United States	70 participants n=39 Participants

PRIMARY outcome

Timeframe: Entire duration of surgery

Population: This only includes participants who were enrolled after the interim analysis, and who had HR data available from the standard intraoperative monitors.

Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Outcome measures

Outcome measures
Measure	ATLASense RAPHAEL Monitoring n=42 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Heart Rate (HR)	0.922 Spearman Correlation Coefficient Standard Deviation 0.074

PRIMARY outcome

Timeframe: Entire duration of surgery

Population: Only participants who were enrolled after the interim analysis was performed and who had respiratory rate data available from standard intraoperative monitors. (Note: Intraoperative data from standard monitors was unretrievable from EPIC for two of the subjects)

Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Outcome measures

Outcome measures
Measure	ATLASense RAPHAEL Monitoring n=40 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Respiratory Rate (RR)	0.714 Weighted Spearman Correlation Coefficien Standard Deviation 0.168

SECONDARY outcome

Timeframe: Entire duration of surgery

Population: All participants who had HR or RR data available from standard intraoperative monitors.

Length and frequency of gaps in data collection when the ATLASense RAPHAEL PolyMonitor or standard intraoperative monitors did not collect data.

Outcome measures

Outcome measures
Measure	ATLASense RAPHAEL Monitoring n=66 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Gaps in Data Collection	15.5 percent of data loss

SECONDARY outcome

Timeframe: Entire duration of surgery

Population: All patients who received continuous blood pressure monitoring via an arterial line for the duration of their procedure.

Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Outcome measures

Outcome measures
Measure	ATLASense RAPHAEL Monitoring n=14 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Blood Pressure (Mean Arterial Pressure)	0.065 Weighted Spearman Correlation Coefficien Standard Deviation 0.113

SECONDARY outcome

Timeframe: Entire duration of surgery

Population: All patients enrolled after the interim analysis and who had temperature data available from standard intraoperative monitors. (Note: Intraoperative data from standard monitors was unretrievable from EPIC for two of the subjects)

Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor

Outcome measures

Outcome measures
Measure	ATLASense RAPHAEL Monitoring n=40 Participants All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. ATLASense RAPHAEL PolyMonitor: All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Core Body Temperature	0.158 Weighted Spearman Correlation Coefficien Standard Deviation 0.358

Adverse Events

ATLASense RAPHAEL Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research, Department of Anesthesiology

Henry Ford Health

Phone: 313-771-7128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place