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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00228293
Other study ID # IRB11754B
Secondary ID IDE G020121
Status Terminated
Phase Phase 2/Phase 3
First received September 23, 2005
Last updated September 20, 2013
Start date December 2002
Est. completion date September 2005

Study information

Verified date September 2013
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
investigational monitor/defibrillator with CPR feedback


Locations

Country Name City State
United States University of Chicago Hospitals Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Laerdal Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary parameters of CPR quality:
Primary chest compression rate
Primary chest compression depth
Primary ventilation rate
Primary ventilation depth
Primary CPR pause times
Secondary return of spontaneous circulation (ROSC)
Secondary survival to hospital discharge
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