Assessing CPR Quality During In-Hospital Cardiac Arrest - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiac Arrest	Device: investigational monitor/defibrillator with CPR feedback	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Assessment of Cardiopulmonary Resuscitation Quality During In-Hospital Cardiac Arrest

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Health Facilities

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

parameters of CPR quality:
chest compression rate
chest compression depth
ventilation rate
ventilation depth
CPR pause times

Secondary Outcome Measures:

return of spontaneous circulation (ROSC)
survival to hospital discharge


Estimated Enrollment:	200
Study Start Date:	December 2002
Estimated Study Completion Date:	September 2005

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, 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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patient with cardiac arrest hospitalized at University of Chicago Hospitals

Exclusion Criteria:

pregnant
arrest in ER or OR
pediatric patient
patient DNR, no CPR given
no CPR given for other reasons (e.g. shock only)

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00228293

Locations


United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Laerdal Medical

Investigators


Principal Investigator:	Lance B Becker, MD	Professor of Medicine, University of Chicago

More Information

Publications:

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 Jan 19;293(3):305-10.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Edelson DP, Litzinger B, Arora V, Walsh D, Kim S, Lauderdale DS, Vanden Hoek TL, Becker LB, Abella BS. Improving in-hospital cardiac arrest process and outcomes with performance debriefing. Arch Intern Med. 2008 May 26;168(10):1063-9. doi: 10.1001/archinte.168.10.1063.

Kramer-Johansen J, Edelson DP, Abella BS, Becker LB, Wik L, Steen PA. Pauses in chest compression and inappropriate shocks: a comparison of manual and semi-automatic defibrillation attempts. Resuscitation. 2007 May;73(2):212-20. Epub 2007 Jan 22.


Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00228293 History of Changes
Other Study ID Numbers:	IRB11754B, IDE G020121
Study First Received:	September 23, 2005
Last Updated:	September 20, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:


cardiac arrest CPR

Additional relevant MeSH terms:


Heart Arrest Cardiovascular Diseases Heart Diseases

ClinicalTrials.gov processed this record on February 27, 2015