Intraoperative Monitoring
Conditions
Keywords
heart rate, respiratory rate, blood pressure, temperature
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 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.
Interventions
DEVICEATLASense RAPHAEL PolyMonitor
All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
No masking
Intervention model description
Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate (HR) | Entire duration of surgery | Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor |
| Respiratory Rate (RR) | Entire duration of surgery | Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gaps in Data Collection | Entire duration of surgery | Length and frequency of gaps in data collection when the ATLASense RAPHAEL PolyMonitor or standard intraoperative monitors did not collect data. |
| Blood Pressure (Mean Arterial Pressure) | Entire duration of surgery | Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor |
| Core Body Temperature | Entire duration of surgery | Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | ATLASense RAPHAEL Monitoring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Heart Rate (HR)
Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLASense RAPHAEL Monitoring | Heart Rate (HR) | 0.922 Spearman Correlation Coefficient | Standard Deviation 0.074 |
Bland-Altman
Primary
Respiratory Rate (RR)
Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLASense RAPHAEL Monitoring | Respiratory Rate (RR) | 0.714 Weighted Spearman Correlation Coefficien | Standard Deviation 0.168 |
Secondary
Blood Pressure (Mean Arterial Pressure)
Minute-by-minute blood pressure measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Time frame: Entire duration of surgery
Population: All patients who received continuous blood pressure monitoring via an arterial line for the duration of their procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLASense RAPHAEL Monitoring | Blood Pressure (Mean Arterial Pressure) | 0.065 Weighted Spearman Correlation Coefficien | Standard Deviation 0.113 |
Secondary
Core Body Temperature
Minute-by-minute core body temperature measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATLASense RAPHAEL Monitoring | Core Body Temperature | 0.158 Weighted Spearman Correlation Coefficien | Standard Deviation 0.358 |
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.
Time frame: Entire duration of surgery
Population: All participants who had HR or RR data available from standard intraoperative monitors.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATLASense RAPHAEL Monitoring | Gaps in Data Collection | 15.5 percent of data loss |