Assessing CPR Quality During In-Hospital Cardiac Arrest

This study has been terminated.

Sponsor:

Collaborator:

Laerdal Medical

Information provided by:

University of Chicago

ClinicalTrials.gov Identifier:

NCT00228293

First received: September 23, 2005

Last updated: September 28, 2006

Last verified: September 2006

History of Changes

Tracking Information

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

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

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

return of spontaneous circulation (ROSC)
survival to hospital discharge

Original Secondary Outcome Measures ^ICMJE

1. return of spontaneous circulation (ROSC)
2. survival to hospital discharge

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessing CPR Quality During In-Hospital Cardiac Arrest

Official Title ^ICMJE

Assessment of Cardiopulmonary Resuscitation Quality During In-Hospital Cardiac Arrest

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

200

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

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

Investigators ^ICMJE

Principal Investigator:

Lance B Becker, MD

Professor of Medicine, University of Chicago

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

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