Tempus Pro Monitor Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-25

Study Completion Date

2024-08-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sudden Cardiac Arrest Emergency Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Standard of Care

Standard of Care for emergency care

Standard of Care

Intervention Type DIAGNOSTIC_TEST

Standard of care for emergency events per local guidelines.

Interventions

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Standard of Care

Standard of care for emergency events per local guidelines.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)