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Completed

NCT Number: NCT05291949

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATLASense RAPHAEL PolyMonitor

Device

All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.

Primary outcomes

  1. Heart Rate (HR)

    Time frame: Entire duration of surgery

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

  2. Respiratory Rate (RR)

    Time frame: Entire duration of surgery

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

Secondary outcomes

  1. Gaps in Data Collection

    Time frame: 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.

  2. Blood Pressure (Mean Arterial Pressure)

    Time frame: Entire duration of surgery

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

  3. Core Body Temperature

    Time frame: Entire duration of surgery

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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Acronym: ATLASense

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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