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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest, Out-Of-Hospital
• Intervention / Treatment: Device: Head Up CPR based bundle of care

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Johanna C Moore, MD, MS; Phone Number: 612 873 4908; Email: johanna.moore@hcmed.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin Healthcare Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with out-of-hospital cardiac arrest in areas where emergency medical services that have a Head Up CPR based system of care in their cardiac arrest protocol as part of routine clinical care.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Head Up CPR based bundle of care; All patients in the registry receive the Head Up CPR based bundle of care.

Device: Head Up CPR based bundle of care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of Spontaneous Circulation	Presence of cardiac activity with a perfusing blood pressure	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.
Survival	If the patient survived admission to the hospital until hospital discharge	The time period in which this outcome will occur will vary, may extend up to 60 days.
Survival with Favorable Neurological Function	If the patient survived admission to the hospital until hospital discharge with favorable Cerebral Performance Category (CPC) Score as defined CPC 1 or 2.	The time period in which this outcome will occur will vary, may extend up to 60 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal CO2 (ETCO2)	ETCO2 is an indirect measure of perfusion during CPR	ETCO2 will be measured continuously while the patient is receiving CPR. This time period is estimated to occur up to 40 minutes.
Cerebral Oximetry	Near-infrared spectroscopy (NIRS) capable of measuring regional tissue oxygenation.	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.

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: Johanna C Moore, MD, MS, Hennepin Healthcare Research Institute

Publications and helpful links

General Publications

• Moore JC, Duval S, Lick C, Holley J, Scheppke KA, Salverda B, Rojas-Salvador C, Jacobs M, Nystrom P, Quinn R, Adams PJ, Debaty GP, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy P, Coyle C, Grizzard E, Garay S, Lurie KG, Pepe PE. Faster time to automated elevation of the head and thorax during cardiopulmonary resuscitation increases the probability of return of spontaneous circulation. Resuscitation. 2022 Jan;170:63-69. doi: 10.1016/j.resuscitation.2021.11.008. Epub 2021 Nov 15.
• Moore JC, Pepe PE, Scheppke KA, Lick C, Duval S, Holley J, Salverda B, Jacobs M, Nystrom P, Quinn R, Adams PJ, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy PM, Coyle C, Grizzard E, Garay S, Crowe RP, Lurie KG, Debaty GP, Labarere J. Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival. Resuscitation. 2022 Oct;179:9-17. doi: 10.1016/j.resuscitation.2022.07.039. Epub 2022 Aug 4.
• Bachista KM, Moore JC, Labarere J, Crowe RP, Emanuelson LD, Lick CJ, Debaty GP, Holley JE, Quinn RP, Scheppke KA, Pepe PE. Survival for Nonshockable Cardiac Arrests Treated With Noninvasive Circulatory Adjuncts and Head/Thorax Elevation. Crit Care Med. 2024 Feb 1;52(2):170-181. doi: 10.1097/CCM.0000000000006055. Epub 2024 Jan 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 1281037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No