Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189423
Status:
TERMINATED
Last Update Posted:
2017-12-08
First Post:
2005-09-12
Brief Title:
ResQ Trial Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
Sponsor:
Advanced Circulatory Systems
Organization:
Advanced Circulatory Systems
Study Overview
Official Title:
ResQ Trial Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to lack of funding Follow-up completed for all enrolled subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ResQ
Brief Summary:
The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation ACD-CPR with an impedance threshold device ITD compared to conventional standard cardiopulmonary resuscitation S-CPR will impact the neurologic recovery and survival to hospital discharge following out-of-hospital cardiac arrest
Detailed Description:
Despite receiving conventional standard CPR S-CPR most patients who experience out-of-hospital cardiac arrest die prior to arriving at a hospital At the present time the hospital discharge rate following out-of-hospital nontraumatic cardiac arrest in adults in the United States is estimated to be less than 5 Many factors contribute to the current poor survival statistics including the inefficiency of the technique itself CPR provides only 10 to 20 of normal myocardial perfusion and only 20 to 30 of physiologically normal cerebral perfusion
A new method of CPR that combines ACD and an ITD ACD-CPRITD has been shown in animal models and in clinical trials conducted in Europe to provide significantly more blood flow to the vital organs and to improve survival rates when compared to S-CPR or ACD-CPR alone
ACD-CPRITD works by decreasing intrathoracic pressure during the chest wall recoil or decompression phase of CPR creating a vacuum within the thorax relative to the rest of the body When compared with controls use of ACD-CPRITD a enhances blood return to the thorax during the chest wall recoil phase b enhances blood flow to the heart and brain c provides real-time feedback to rescuers to maintain high-quality CPR d improves overall CPR efficiency and as a result of the forgoing e improves short-term survival rates
The sponsor and others recently evaluated the effectiveness of the combination of conventional manual standard CPRITD in animals and humans The ITD increased short-term survival rates in these studies as well Two clinical trials were performed in Milwaukee Wisconsin under IDE G980125 Both compared S-CPR with either a sham nonfunctional or placebo or active functional ITD The results from the hemodynamic study demonstrated that systolic blood pressure the primary end point increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD P less than 005 Intensive care unit admission rate was the primary end point of the clinical outcome study
Comparisons The objective of this two-arm multisite randomized pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR compared to ACD-CPRITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems
A new method of CPR that combines ACD and an ITD ACD-CPRITD has been shown in animal models and in clinical trials conducted in Europe to provide significantly more blood flow to the vital organs and to improve survival rates when compared to S-CPR or ACD-CPR alone
ACD-CPRITD works by decreasing intrathoracic pressure during the chest wall recoil or decompression phase of CPR creating a vacuum within the thorax relative to the rest of the body When compared with controls use of ACD-CPRITD a enhances blood return to the thorax during the chest wall recoil phase b enhances blood flow to the heart and brain c provides real-time feedback to rescuers to maintain high-quality CPR d improves overall CPR efficiency and as a result of the forgoing e improves short-term survival rates
The sponsor and others recently evaluated the effectiveness of the combination of conventional manual standard CPRITD in animals and humans The ITD increased short-term survival rates in these studies as well Two clinical trials were performed in Milwaukee Wisconsin under IDE G980125 Both compared S-CPR with either a sham nonfunctional or placebo or active functional ITD The results from the hemodynamic study demonstrated that systolic blood pressure the primary end point increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD P less than 005 Intensive care unit admission rate was the primary end point of the clinical outcome study
Comparisons The objective of this two-arm multisite randomized pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR compared to ACD-CPRITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems
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 |
|---|---|---|---|
| 43-0303-000 | US NIH GrantContract | None | httpsreporternihgovquickSearch2R44HL065851-03 |
| R44HL065851-03 | NIH | None | None |
| 2R44HL065851-03 | NIH | None | None |