Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228293
Status:
TERMINATED
Last Update Posted:
2013-09-23
First Post:
2005-09-23
Brief Title:
Assessing CPR Quality During In-Hospital Cardiac Arrest
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Assessment of Cardiopulmonary Resuscitation Quality During In-Hospital Cardiac Arrest
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Using an investigational monitordefibrillator that passively records CPR quality parameters including chest compression rate and depth and ventilation rate and volume we are prospectively recording CPR quality during sequential in-hospital cardiac arrests at the University of Chicago Hospitals Using an audio feedback system linked to this device we are studying whether such audio feedback improves CPR quality when provided to rescuers trained in the use of the device
Detailed Description:
Patients who suffer cardiac arrest during their hospitalization at the University of Chicago hospitals are given CPR and other resuscitation measures by trained physician and nurse teams This care is given with the use of defibrillators to monitor cardiac rhythm as well as provide defibrillation as needed
We have worked closely with engineers at Laerdal Medical Corporation to develop a defibrillator that passively monitors the quality of CPR via additional external sensors see details in the following reference Abella BS Alvarado JP Myklebust H Edelson DP Barry A OHearn N Vanden Hoek TL Becker LB Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest JAMA 2005293305-10
Patients who suffer in-hospital arrest are enrolled provided they are over 16 years of age are not pregnant and are not in the operating room or emergency room setting with mechanisms to satisfy IRB waiver of consent provisions These patients receive the same care as before the study but CPR parameters are recorded by the device In addition the device provides audiovisual coaching in CPR based on the actual performance of CPR as measured
We hypothesize that this coaching will improve CPR quality and hopefully improve survival from cardiac arrest
The first phase of investigation is now complete where patients were enrolled and studied without feedback baseline group Now we are enrolling patients into a second group with feedback provided Enrollment is nearly complete for this second group We will then evaluate the baseline and feedback groups to ascertain whether CPR improved over the two cohorts
We have worked closely with engineers at Laerdal Medical Corporation to develop a defibrillator that passively monitors the quality of CPR via additional external sensors see details in the following reference Abella BS Alvarado JP Myklebust H Edelson DP Barry A OHearn N Vanden Hoek TL Becker LB Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest JAMA 2005293305-10
Patients who suffer in-hospital arrest are enrolled provided they are over 16 years of age are not pregnant and are not in the operating room or emergency room setting with mechanisms to satisfy IRB waiver of consent provisions These patients receive the same care as before the study but CPR parameters are recorded by the device In addition the device provides audiovisual coaching in CPR based on the actual performance of CPR as measured
We hypothesize that this coaching will improve CPR quality and hopefully improve survival from cardiac arrest
The first phase of investigation is now complete where patients were enrolled and studied without feedback baseline group Now we are enrolling patients into a second group with feedback provided Enrollment is nearly complete for this second group We will then evaluate the baseline and feedback groups to ascertain whether CPR improved over the two cohorts
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 |
|---|---|---|---|
| IDE G020121 | None | None | None |