Head‑up, device‑assisted controlled elevation CPR for out‑of‑hospital cardiac arrest

International Device Assisted Controlled Sequential Elevation CPR Registry

This registry will track how head‑up, device‑assisted CPR (using an impedance threshold device plus either active compression‑decompression or mechanical compressions) works for adults who experience out‑of‑hospital cardiac arrest.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hennepin Healthcare Research Institute (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT05588024 on ClinicalTrials.gov

What this trial studies

This is a prospective observational registry collecting de‑identified data from EMS systems in the US and Europe that have implemented a head‑up CPR protocol combined with an impedance threshold device and either active compression‑decompression or automated mechanical compression. Participating systems submit patient demographics, detailed arrest care information, and outcomes from before and after implementation of the head‑up bundle, with a current focus on cases where the device combination was applied rapidly. All devices used in the registry have received FDA 510(k) clearance. The registry aggregates real‑world outcomes to monitor usage patterns and clinical results across diverse EMS settings.

Who should consider this trial

Good fit: Adults (18+) who suffer an out‑of‑hospital cardiac arrest and receive device‑assisted controlled elevation of the head and thorax together with an impedance threshold device plus either active compression‑decompression or automated mechanical CPR.

Not a fit: Patients who do not receive the combined head‑up device and ITD with ACD or mechanical CPR (including most in‑hospital arrests), and incarcerated individuals who are excluded, are unlikely to be represented or receive benefit from this registry.

Why it matters

Potential benefit: If successful, this work could show that combining controlled head‑up positioning with an ITD and ACD or mechanical CPR improves survival and neurologic outcomes after out‑of‑hospital cardiac arrest.

How similar studies have performed: Preclinical studies and small observational reports suggest physiologic and short‑term outcome benefits for head‑up CPR approaches, but large‑scale clinical evidence is still limited.

Eligibility criteria

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

Where this trial is running

Minneapolis, Minnesota

• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Johanna C Moore, MD, MS — Hennepin Healthcare Research Institute
• Study coordinator: Johanna C Moore, MD, MS

Conditions Cardiac Arrest, Out-Of-Hospital