Tempus Pro Monitor Registry

NCT05587764 | Completed FDA Device

• 1 other identifier: CCTCRDTTempusProRegi20211168
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sudden Cardiac Arrest; Emergency Care

Keywords

Tempus Pro; IntelliSpace Corsium

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Number of all activated alarms

  through study completion, an average of 1 year

• IntelliSpace Corsium transmission

  through study completion, an average of 1 year

Other Outcomes (2)

• Adverse Device Effects

  through study completion, an average of 1 year

• Device Deficiencies

  through study completion, an average of 1 year

Study Arms (1)

Standard of Care

Standard of Care for emergency care

Diagnostic Test: Standard of Care

Interventions

Standard of Care DIAGNOSTIC_TEST

Standard of care for emergency events per local guidelines.

Standard of Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).

You may qualify if:

• 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)

You may not qualify if:

• None defined

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• North American Science Associates, LLC: collaborator

Study Sites (1)

Philips

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Lyon, MB CHB (HONS) MD MRCP FRCEM

  CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 20, 2022
• Study Start: April 25, 2024
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)