Intraoperative MonitoringATLASenseNCT05291949
Comparison of Intraoperative HR and RR Acquired Via ATLASense Raphael PolyMonitor and Standard Intraoperative Monitors
A study testing ATLASense RAPHAEL PolyMonitor in people with Intraoperative Monitoring, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Monitoring
- What is being tested?
- ATLASense RAPHAEL PolyMonitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Adult males or females (above the age of 18)
- Scheduled to undergo general anesthesia during elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraoperative Heart Rate and Respiratory Rate 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.
Read the 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.
- Conditions
- Intraoperative Monitoring
- Being tested
- ATLASense RAPHAEL PolyMonitor
- Keywords
- heart rate, respiratory rate, blood pressure, temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLASense RAPHAEL PolyMonitorDevice
All patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery.
| Study group | Role | What they receive |
|---|---|---|
| ATLASense RAPHAEL monitoring | Experimental | All patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. Receives: Device: ATLASense RAPHAEL PolyMonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (HR)
Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Measured: 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
Measured: Entire duration of surgery
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Entire duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start18 Oct 2021
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraoperative MonitoringStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor J. Szymanski MD, MBA, Henry Ford Health System
- Investigators
- Trevor Szymanski, MD, MBA, Principal investigator, Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291949
- Sponsor's protocol ID
- 14139
- Acronym
- ATLASense
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2022
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors
- ClinicalTrials.gov ID
- NCT05291949
- Acronym / sponsor ID
- ATLASense / 14139
- Conditions
- Intraoperative Monitoring
- Keywords
- heart rate, respiratory rate, blood pressure, temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient receives monitoring by all standard intraoperative monitors in addition to monitoring by the ATLASense RAPHAEL PolyMonitor during their surgery.
| Arm | Type | Receives |
|---|---|---|
| ATLASense RAPHAEL monitoring | Experimental | Device: ATLASense RAPHAEL PolyMonitorAll patients receive monitoring by ATLASense RAPHAEL PolyMonitor for duration of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Adult males or females (above the age of 18)
- Scheduled to undergo general anesthesia during elective surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATLASense RAPHAEL PolyMonitorAll patients will be monitored using the ATLASense RAPHAEL PolyMonitor during their surgery. | Device | ATLASense RAPHAEL monitoring |
Primary outcome
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
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
3 secondary outcomes
Gaps in Data Collection
Time frame: Entire duration of surgery
Blood Pressure (Mean Arterial Pressure)
Time frame: Entire duration of surgery
Core Body Temperature
Time frame: Entire duration of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor Szymanski, MD, MBA principal investigator
Medical Co-Director, Surgical Services, Division Head, Cardiac Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLASense RAPHAEL PolyMonitor in people with Intraoperative Monitoring, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (HR) (time frame: Entire duration of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.