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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATLASense RAPHAEL monitoring | Experimental | All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATLASense RAPHAEL PolyMonitor | Device | All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trevor Szymanski, MD, MBA | Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate (HR) | Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | This only includes participants who were enrolled after the interim analysis, and who had HR data available from the standard intraoperative monitors. | Posted | Mean | Standard Deviation | Spearman Correlation Coefficient | Entire duration of surgery |
|
For the duration of procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research, Department of Anesthesiology | Henry Ford Health | 313-771-7128 | knowak2@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2022 | Jun 16, 2023 | Prot_SAP_000.pdf |
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Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.
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No masking
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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 |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Respiratory Rate (RR) | Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | 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) | Posted | Mean | Standard Deviation | Weighted Spearman Correlation Coefficien | Entire duration of surgery |
|
|
|
| Secondary | 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. | All participants who had HR or RR data available from standard intraoperative monitors. | Posted | Number | percent of data loss | Entire duration of surgery |
|
|
|
| Secondary | Blood Pressure (Mean Arterial Pressure) | Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | All patients who received continuous blood pressure monitoring via an arterial line for the duration of their procedure. | Posted | Mean | Standard Deviation | Weighted Spearman Correlation Coefficien | Entire duration of surgery |
|
|
|
| Secondary | Core Body Temperature | Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor | 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) | Posted | Mean | Standard Deviation | Weighted Spearman Correlation Coefficien | Entire duration of surgery |
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| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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