Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01325870
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2011-03-28
Brief Title:
Hemodynamic Effects of Standard Cardiopulmonary Resuscitation CPR Active Compression Decompression CPR With an Inspiratory Impedance Device and Standard CPR With an Intrathoracic Pressure Regulator During Out-of-hospital Cardiac Arrest
Sponsor:
Advanced Circulatory Systems
Organization:
Advanced Circulatory Systems
Study Overview
Official Title:
Comparison of Standard Cardiopulmonary Resuscitation Alone Versus Active Compression Decompression Cardiopulmonary Resuscitation Plus an Impedance Threshold Device Versus Standard Cardiopulmonary Resuscitation Plus an Intrathoracic Pressure Regulator on Arterial Blood Pressures During Out-of-Hospital Cardiac Arrest
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
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:
More than 300000 Americans experience out-of-hospital cardiac arrest annually with overall survival rates averaging less than 5 Low survival rates persist in part because manual chest compressions and ventilation termed standard cardiopulmonary resuscitation S-CPR is an inherently inefficient process providing less than 25 of normal blood flow to the heart and the brain Hemodynamics are often compromised further by poor S-CPR techniques especially inadequate chest compression and incomplete chest recoil Active Compression Decompression CPR ACD-CPR is performed with a hand-held device that is attached to the patients chest and also includes a handle containing a metronome and force gauge to guide proper compression rate depth and complete chest wall recoil The impedance threshold device ITD is designed for rapid connection to an airway adjunct eg facemask or endotracheal tube and allows for positive pressure ventilation while also impeding passive inspiratory gas exchange during chest wall decompression Prior studies have shown that the combination of ACD-CPR ITD enhances refilling of the heart after each compression by augmenting negative intrathoracic pressure during the decompression phase of CPR resulting in improved cardiac and cerebral perfusion The intrathoracic pressure regulator ITPR is a next generation inspiratory impedance therapy The ITPR uses a regulated external vacuum source to lower the negative intrathoracic pressure and is therefore less dependent on the quality of CPR eg completeness of chest wall recoil The ITPR generates a pre-set continuous and controlled expiratory phase negative intrathoracic pressure that is interrupted only when positive pressure ventilation is needed to maintain oxygenation and provide gas exchange
The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR ACD- CPR ITD and S-CPR ITPR in patients with out-of-hospital cardiac arrest
The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR ACD- CPR ITD and S-CPR ITPR in patients with out-of-hospital cardiac arrest
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44HL082088 | NIH | None | httpsreporternihgovquickSearch2R44HL082088 |