Assessing CPR Quality During In-Hospital Cardiac Arrest
|First Received Date ICMJE||September 23, 2005|
|Last Updated Date||September 28, 2006|
|Start Date ICMJE||December 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00228293 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Assessing CPR Quality During In-Hospital Cardiac Arrest|
|Official Title ICMJE||Assessment of Cardiopulmonary Resuscitation Quality During In-Hospital Cardiac Arrest|
Using an investigational monitor/defibrillator 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.
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, O'Hearn N, Vanden Hoek TL, Becker LB. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005;293:305-10).
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 audio/visual "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 Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Cardiac Arrest|
|Intervention ICMJE||Device: investigational monitor/defibrillator with CPR feedback|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||September 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00228293|
|Other Study ID Numbers ICMJE||IRB11754B, IDE G020121|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Chicago|
|Collaborators ICMJE||Laerdal Medical|
|Information Provided By||University of Chicago|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP