Tempus Pro Monitor Registry

Study Overview
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Brief Summary
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A multicenter, prospective and retrospective, observational, post market study.

Detailed Description
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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.

Official Title
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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

Conditions
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Sudden Cardiac Arrest, Emergency Care

Intervention / Treatment
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* Diagnostic Test: Standard of Care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Standard of Care for emergency care | Diagnostic Test: Standard of Care<br>* Standard of care for emergency events per local guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician assessment of 12-lead ECG reports | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tempus Pro, IntelliSpace Corsium