Tempus Pro Monitor Registry

Completed

• Conditions: Emergency Care; Sudden Cardiac Arrest
• Interventions: Diagnostic Test: Standard of Care

• Registration Number: NCT05587764
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-20
• Study Start: 2024-04-25
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of Care for emergency care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Philips; 🇺🇸 Pittsburgh, Pennsylvania, United States