Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Assessing CPR Quality During In-Hospital Cardiac Arrest

This study has been terminated.
Sponsor:
Collaborator:
Laerdal Medical
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00228293
First received: September 23, 2005
Last updated: September 20, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 23, 2014