Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| North American Science Associates, LLC | UNKNOWN |
Not provided
Not provided
Not provided
A multicenter, prospective and retrospective, observational, post market 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Standard of Care for emergency care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Diagnostic Test | Standard of care for emergency events per local guidelines. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Device Effects | Frequency of Adverse Device Effects (ADE) related to device users - collected from Incident Reporting | through study completion, an average of 1 year |
| Device Deficiencies | 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 |
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Lyon, MB CHB (HONS) MD MRCP FRCEM | CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips | Pittsburgh | Pennsylvania | 15206 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| through study completion, an average of 1 year |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |