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NCT Number: NCT05588024

International Device Assisted Controlled Sequential Elevation CPR Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is at least 18 years of age
  • 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.
  • 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
  • Subject receives device assisted controlled elevation of the head and thorax.

Exclusion criteria

  • Prisoners

Treatment and study plan

Head Up CPR based bundle of care

Device

All patients in this registry receive the intervention, a Head Up Cardiopulmonary Resuscitation (CPR) based bundle of care. This bundle of care includes the use of multiple FDA approved devices. The components of the Head Up CPR bundle are 1) a single or combination of CPR methods including manual, active-compression decompression CPR, or automated suction-cup based CPR 2) An impedance threshold device 3) An automated patient positioning device capable of elevating the head and thorax

Primary outcomes

  1. Return of Spontaneous Circulation

    Time frame: From the start of CPR to the presence of cardiac activity. The time period in which this outcome will varies and is estimated to range from 0 minutes up to around 40 minutes.

    Presence of cardiac activity with a perfusing blood pressure

  2. Survival

    Time frame: The time period in which this outcome will occur will vary, may extend up to 60 days.

    If the patient survived admission to the hospital until hospital discharge

  3. Survival with Favorable Neurological Function

    Time frame: The time period in which this outcome will occur will vary, may extend up to 60 days.

    If the patient survived admission to the hospital until hospital discharge with favorable Cerebral Performance Category (CPC) Score as defined CPC 1 or 2.

Secondary outcomes

  1. End tidal CO2 (ETCO2)

    Time frame: ETCO2 will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.

    ETCO2 is an indirect measure of perfusion during CPR

  2. Cerebral Oximetry

    Time frame: If the participating EMS system in the registry uses NIRS cerebral oximetry, it will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.

    Near-infrared spectroscopy (NIRS) capable of measuring regional tissue oxygenation.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna C Moore, MD, MS

CONTACT

[email protected]

612 873 4908

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 20, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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