Cardiac Arrest, Out-Of-Hospital
Conditions
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.
Interventions
DEVICEHead 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
Sponsors
Hennepin Healthcare Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJohanna C Moore, MD, MS
Outcome results
None listed