International Device Assisted Controlled Sequential Elevation CPR Registry

Recruiting

• Conditions: Cardiac Arrest, Out-Of-Hospital
• Interventions: Device: Head Up CPR based bundle of care

• Registration Number: NCT05588024
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief 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.

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 Timeline

• Study Start: 2020-03-23
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head Up CPR based bundle of care	Head Up CPR based bundle of care	All patients in the registry receive the Head Up CPR based bundle of care.

Primary Outcome Measures

Name	Time	Method
Return of Spontaneous Circulation	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
Survival with Favorable Neurological Function	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.
Survival	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

Secondary Outcome Measures

Name	Time	Method
End tidal CO2 (ETCO2)	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
Cerebral Oximetry	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.

Trial Locations

Locations (1)

Hennepin Healthcare Research Institute; 🇺🇸 Minneapolis, Minnesota, United States