Clinical trial NCT05291949: Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors
Official title: Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Monitoring
Keywords: heart rate
respiratory rate
blood pressure
temperature
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate (HR)
timeFrame: Entire duration of surgery
measure: Respiratory Rate (RR)
timeFrame: Entire duration of surgery
Secondary outcomes:
measure: Gaps in Data Collection
timeFrame: Entire duration of surgery
measure: Blood Pressure (Mean Arterial Pressure)
timeFrame: Entire duration of surgery
measure: Core Body Temperature
timeFrame: Entire duration of surgery
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia
name: Trevor Szymanski, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: