Tempus Pro Monitor Registry

March 5, 2025 updated by: Philips Clinical & Medical Affairs Global

A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine

A multicenter, prospective and retrospective, observational, post market study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Philips

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).

Description

Inclusion Criteria:

Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)

One or more 12-lead ECG recorded

Use of 3 or more of the following sensors to measure vital signs

  • NIBP (Non-Invasive Blood Pressure)
  • HR (Heart Rate)
  • SpO2 (Oxygen Saturation)
  • PVI (Pleth Variability Index)
  • SpCO (Carboxyhemoglobin)
  • SpOC (Oxygen Content)
  • SpHb (Total Hemoglobin)
  • SpMet (Methemoglobin Saturation)
  • EtCO2 (End-tidal Carbon Dioxide)

Exclusion Criteria:

  • None defined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of Care
Standard of Care for emergency care
Diagnostic test: Standard of Care
Standard of care for emergency events per local guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician assessment of 12-lead ECG reports
Time Frame: through study completion, an average of 1 year
The proportion of 12-lead ECG pairs that are identical, after a cardiologist's review of printouts from Corsium IntelliSpace (transmitted) ECG and the original ECG from the Tempus Pro device.
through study completion, an average of 1 year
Diagnostic quality of 12-lead
Time Frame: through study completion, an average of 1 year
The printed patient record ECG will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality.
through study completion, an average of 1 year
Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
Time Frame: through study completion, an average of 1 year
The number and proportion of patient vital sign data points, comparing direct data with identical units of measure from printouts from IntelliSpace Corsium (transmitted) vital signs and the original vital signs from the Tempus Pro device.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of all activated alarms
Time Frame: through study completion, an average of 1 year
The 'Summary Record of Care' indicates all alarms - for all alarm-settable parameters - were activated at the thresholds set by the user, as indicated in the 'Technical Log'
through study completion, an average of 1 year
IntelliSpace Corsium transmission
Time Frame: through study completion, an average of 1 year
The Summary Record of Care (SRoC) data transmission from Tempus Pro to IntelliSpace Corsium will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality of the transmission.
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Device Effects
Time Frame: through study completion, an average of 1 year
Frequency of Adverse Device Effects (ADE) related to device users - collected from Incident Reporting
through study completion, an average of 1 year
Device Deficiencies
Time Frame: through study completion, an average of 1 year
Frequency of Device Deficiencies (DD) - data collected from the technical data log recorded in the Tempus Pro at each Monitoring Event and from Product Complaint Reports
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

North American Science Associates, LLC

Investigators

  • Principal Investigator: Richard Lyon, MB CHB (HONS) MD MRCP FRCEM, CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTCRDTTempusProRegi20211168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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