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Assessing CPR Quality During In-Hospital Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
investigational monitor/defibrillator with CPR feedback
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, CPR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Chicago Hospitals

Outcomes

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

Full Information

First Posted
September 23, 2005
Last Updated
September 20, 2013
Sponsor
University of Chicago
Collaborators
Laerdal Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00228293
Brief Title
Assessing CPR Quality During In-Hospital Cardiac Arrest
Official Title
Assessment of Cardiopulmonary Resuscitation Quality During In-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Laerdal Medical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, CPR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
investigational monitor/defibrillator with CPR feedback
Primary Outcome Measure Information:
Title
parameters of CPR quality:
Title
chest compression rate
Title
chest compression depth
Title
ventilation rate
Title
ventilation depth
Title
CPR pause times
Secondary Outcome Measure Information:
Title
return of spontaneous circulation (ROSC)
Title
survival to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance B Becker, MD
Organizational Affiliation
Professor of Medicine, University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15657323
Citation
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. doi: 10.1001/jama.293.3.305.
Results Reference
result
PubMed Identifier
18504334
Citation
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.
Results Reference
derived
PubMed Identifier
17241734
Citation
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. doi: 10.1016/j.resuscitation.2006.09.006. Epub 2007 Jan 22.
Results Reference
derived

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Assessing CPR Quality During In-Hospital Cardiac Arrest

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