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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sudden Cardiac Arrest
- Sponsor
- Philips Clinical & Medical Affairs Global
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinician assessment of 12-lead ECG reports
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A multicenter, prospective and retrospective, observational, post market study.
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.
Investigators
Eligibility Criteria
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)
Exclusion Criteria
- •None defined
Outcomes
Primary Outcomes
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.
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.
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
- Number of all activated alarms(through study completion, an average of 1 year)
- IntelliSpace Corsium transmission(through study completion, an average of 1 year)