International Device Assisted Controlled Sequential Elevation CPR Registry

Last updated: June 9, 2025
Sponsor: Hennepin Healthcare Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Head Up CPR based bundle of care

Clinical Study ID

NCT05588024
1281037
  • Ages > 18
  • All Genders

Study Summary

The purpose of this prospective observational cardiopulmonary resuscitation (CPR) registry is to track the use and clinical outcomes from emergency medical systems across the US and Europe that have implemented a system of care approach applied rapidly to cardiac arrest that includes using the combination of an impedance threshold device (ITD), and either manual active compression-decompression (ACD) CPR device or automated compression device, with a Head Up CPR device.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Patient is at least 18 years of age

  2. Patient is in active cardiac arrest, as defined by presence of either ventricular fibrillation or ventricular tachycardia, or pulseless electrical activity, or asystole at time of enrollment.

  3. Patient receives either a) active-compression decompression cardiopulmonary resuscitation b) automated suction-cup based CPR with an impedance threshold device (ITD) c) manual CPR with an ITD

  4. Subject receives device assisted controlled elevation of the head and thorax.

Exclusion Criteria

  1. Prisoners

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Head Up CPR based bundle of care
Phase:
Study Start date:
March 23, 2020
Estimated Completion Date:
June 30, 2027

Study Description

In 2019, a FDA approved patient positioning device capable of elevating the head and thorax in a controlled manner became commercially available. As emergency medical services are increasingly using this Head Up CPR patient positioning device as part of their standard protocol for cardiac arrest patients, in addition to Active Compression-Decompression (ACD) cardiopulmonary resuscitation with an Impedance Threshold Device (ITD) CPR or with mechanical CPR and the ITD, it is important to monitor how this device is being used, and outcomes of patients who received this Head Up CPR therapy. All of the devices used in this observational registry study have received FDA 510K clearance.

Emergency medical systems (EMS) that have implemented standard cardiac arrest protocols that include the combination of manual CPR with an ITD, an automated CPR device with the ITD, or ACD+ITD CPR, with the Head Up CPR device are asked to be part of the Registry. If a system participates, they are asked for de-identified cardiac arrest data including patient demographics, details of cardiac arrest care, and patient outcomes before and after implementation of the Head Up CPR bundle. De-identified data is kept securely by the study sponsor and PI. The patient data for all systems using this approach to resuscitation are included, with a current focus on patients receiving the device combination rapidly.

Connect with a study center

  • AdvancedCPR Soluations

    Edina, Minnesota 55436
    United States

    Site Not Available

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

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