International Device Assisted Controlled Sequential Elevation CPR Registry

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05588024
Study type	Observational
Source	Advanced CPR Solutions
Contact	Johanna C Moore, MD, MS
Phone	612 873 4908
Email	johanna.moore@hcmed.org
Status	Recruiting
Phase
Start date	March 23, 2020
Completion date	June 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03700203` - Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance
Not yet recruiting	`NCT05325385` - Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest
Withdrawn	`NCT05236920` - Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)	N/A
Enrolling by invitation	`NCT05830422` - Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes
Recruiting	`NCT05482945` - CardioPulmonary Resuscitation With Argon (CPAr) Trial	N/A
Recruiting	`NCT04876222` - Direct or Subacute Coronary Angiography in Patients With Out of Hospital Cardiac Arrest Without Coma.	N/A
Completed	`NCT03112486` - Out-of-hospital Cardiac Arrest (OHCA) Biomarkers
Recruiting	`NCT03826524` - Epinephrine Dose: Optimal Versus Standard Evaluation Trial	Phase 4
Completed	`NCT04891380` - BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study	N/A
Recruiting	`NCT04217551` - Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients	N/A
Enrolling by invitation	`NCT05013333` - AED 3 Post-Approval Study	N/A
Completed	`NCT04791995` - Resuscitation and Capillary Reperfusion
Recruiting	`NCT06334718` - Drone Delivered Defibrillators (The 3D Project).
Withdrawn	`NCT04286204` - New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial	N/A
Recruiting	`NCT06249893` - Feasibility of Doppler Ultrasound for Pulse Detection in Out-of-Hospital Cardiac Arrest Patients
Recruiting	`NCT06165081` - The Association Between Post-resuscitation Time Series Management in the Emergency Department and Short-term Outcomes for Out-of-hospital Cardiac Arrest Patients
Recruiting	`NCT05908500` - Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System	N/A
Recruiting	`NCT04360070` - The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study	N/A
Completed	`NCT03464123` - Brain Oxygenation During Cardiopulmonary Resuscitation
Recruiting	`NCT04972526` - Resuscitative TEE Collaborative Registry

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.