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

Study Overview
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Brief Summary
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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
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The ATLASense Raphael PolyMonitor will be placed on the patient's 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 loss/gaps. Success is also the logistical lessons learned for using this monitor in the intraoperative setting.

Official Title
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Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors

Conditions
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Intraoperative Monitoring

Intervention / Treatment
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* Device: ATLASense RAPHAEL PolyMonitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATLASense RAPHAEL monitoring<br>All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. | Device: ATLASense RAPHAEL PolyMonitor<br>* All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gaps in Data Collection | Length and frequency of gaps in data collection when the ATLASense RAPHAEL PolyMonitor or standard intraoperative monitors did not collect data. | Entire duration of surgery | 
| Blood Pressure (Mean Arterial Pressure) | Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | Entire duration of surgery | 
| Core Body Temperature | Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | Entire duration of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rate, respiratory rate, blood pressure, temperature