Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05588024
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-07-01
Brief Title:
International Device Assisted Controlled Sequential Elevation CPR Registry
Sponsor:
Advanced CPR Solutions
Organization:
Advanced CPR Solutions
Study Overview
Official Title:
International Device Assisted Controlled Sequential Elevation CPR Registry
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ACDITD 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
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 ACDITD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None