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OpenTrials
Completed

NCT Number: NCT05587764

Tempus Pro Monitor Registry

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

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Key information

Conditions

Sudden Cardiac Arrest Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Emergency Care Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Philips

Pittsburgh, Pennsylvania, 15206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard of care

Diagnostic Test

Standard of care for emergency events per local guidelines.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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'

  2. 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.

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

  • North American Science Associates, LLC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Mar 10, 2025

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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