Tempus Pro Monitor Registry

Sudden Cardiac Arrest Clinical Trial

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05587764
• Other study ID #: CCTCRDTTempusProRegi20211168
• Status: Enrolling by invitation
• Start date: April 25, 2024
• Est. completion date: June 28, 2024

Study information

• Verified date: May 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Emergencies
• Emergency Care
• Sudden Cardiac Arrest

Intervention

Diagnostic Test:
• Standard of Care
Standard of care for emergency events per local guidelines.

Locations

Country	Name	City	State
United States	Philips	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	North American Science Associates, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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	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
Secondary	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