Recruiting

Observational Study

Sponsor:

Hennepin Healthcare Research Institute

Code:

NCT05588024

Conditions

Cardiac Arrest, Out-Of-Hospital

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Head Up CPR based bundle of care

Study Details

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.

Conditions

Cardiac Arrest, Out-Of-Hospital

Study ID

NCT05588024

Start date

Mar 23, 2020

Status verified date

Jun, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Head Up CPR based bundle of care

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

Interventions

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

Primary outcome measure

  • 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. ]
  • Survival [ Time Frame: The time period in which this outcome will occur will vary, may extend up to 60 days. ]
  • Survival with Favorable Neurological Function [ Time Frame: The time period in which this outcome will occur will vary, may extend up to 60 days. ]

Central Contacts and Locations

Central contacts

Johanna C Moore, MD, MS

612 873 4908johanna.moore@hcmed.org

Locations

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55415

More Information

Sponsor

Hennepin Healthcare Research Institute

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hennepin Healthcare Research Institute on 2025-06-12.