Emergency Care, Sudden Cardiac Arrest
Conditions
Keywords
Tempus Pro, IntelliSpace Corsium
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.
Interventions
DIAGNOSTIC_TESTStandard of Care
Standard of care for emergency events per local guidelines.
Sponsors
Heartstream US LLC
Philips Clinical & Medical Affairs Global
North American Science Associates Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician assessment of 12-lead ECG reports | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of all activated alarms | 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' |
| IntelliSpace Corsium transmission | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard Lyon, MB CHB (HONS) MD MRCP FRCEM
CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN
Outcome results
None listed