Assessing CPR Quality During In-Hospital Cardiac Arrest

NCT ID: NCT00228293

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Keywords

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cardiac arrest CPR

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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investigational monitor/defibrillator with CPR feedback

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laerdal Medical

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lance B Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, University of Chicago

Locations

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University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15657323 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18504334 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17241734 (View on PubMed)

Other Identifiers

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IDE G020121

Identifier Type: -

Identifier Source: secondary_id

IRB11754B

Identifier Type: -

Identifier Source: org_study_id