Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00640354

Purpose

Automated external defibrillators have improved survival for adult in hospital cardiac arrest. Automated external defibrillators are approved for children aged 1 year and older for out of hospital cardiac arrests. It is unknown whether automated external defibrillators have a role for in hospital pediatric cardiac arrests.

The purpose of study is to compare the management of cardiac rhythm disorders by pediatric residents using an automated external defibrillator versus a standard defibrillator in simulated pediatric cardiac arrests.

It is our hypothesis that residents using an automated external defibrillator will have a shorter time to defibrillation.

Condition	Intervention
Pediatric Residents	Device: Automated external defibrillator Device: Manual defibrillator

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Defibrillation by Automated External Defibrillators Versus Manual Defibrillators in Simulated Pediatric In-Hospital Cardiac Arrests: A Prospective Randomized Controlled Trial of Pediatric Residents

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Time to defibrillation [ Time Frame: Within 5 minutes of the start of the simulated cardiac arrest ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	December 2006
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pediatric residents randomized to having an automated external defibrillator	Device: Automated external defibrillator Residents randomized to this group had an automated external defibrillator available for the simulated cardiac arrest. The automated external defibrillator did not actually discharge energy into the simulated patient
2: Active Comparator Pediatric residents randomized to having a manual defibrillator	Device: Manual defibrillator Residents randomized to this group had a manual defibrillator available for the simulated cardiac arrest. The defibrillator did not actually discharge energy into the simulated patient.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pediatric resident at Baylor College of Medicine

Exclusion Criteria:

Not a pediatric resident at Baylor College of Medicine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640354

Locations

United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Antonio R Mott, MD

Baylor College of Medicine

More Information

Publications:

Rossano JW, Quan L, Kenney MA, Rea TD, Atkins DL. Energy doses for treatment of out-of-hospital pediatric ventricular fibrillation. Resuscitation. 2006 Jul;70(1):80-9. Epub 2006 Jun 8.

Mogayzel C, Quan L, Graves JR, Tiedeman D, Fahrenbruch C, Herndon P. Out-of-hospital ventricular fibrillation in children and adolescents: causes and outcomes. Ann Emerg Med. 1995 Apr;25(4):484-91.

Hickey RW, Cohen DM, Strausbaugh S, Dietrich AM. Pediatric patients requiring CPR in the prehospital setting. Ann Emerg Med. 1995 Apr;25(4):495-501. Review.

Samson RA, Nadkarni VM, Meaney PA, Carey SM, Berg MD, Berg RA; American Heart Association National Registry of CPR Investigators. Outcomes of in-hospital ventricular fibrillation in children. N Engl J Med. 2006 Jun 1;354(22):2328-39.

Samson RA, Berg RA, Bingham R; Pediatric Advanced Life Support Task Force, International Liaison Committee on Resuscitation for the American Heart Association; European Resuscitation Council. Use of automated external defibrillators for children: an update--an advisory statement from the Pediatric Advanced Life Support Task Force, International Liaison Committee on Resuscitation. Pediatrics. 2003 Jul;112(1 Pt 1):163-8. No abstract available.

Deakin CD, Nolan JP; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 3. Electrical therapies: automated external defibrillators, defibrillation, cardioversion and pacing. Resuscitation. 2005 Dec;67 Suppl 1:S25-37. Review. No abstract available.

Larsen MP, Eisenberg MS, Cummins RO, Hallstrom AP. Predicting survival from out-of-hospital cardiac arrest: a graphic model. Ann Emerg Med. 1993 Nov;22(11):1652-8.

Valenzuela TD, Roe DJ, Nichol G, Clark LL, Spaite DW, Hardman RG. Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos. N Engl J Med. 2000 Oct 26;343(17):1206-9.

Zafari AM, Zarter SK, Heggen V, Wilson P, Taylor RA, Reddy K, Backscheider AG, Dudley SC Jr. A program encouraging early defibrillation results in improved in-hospital resuscitation efficacy. J Am Coll Cardiol. 2004 Aug 18;44(4):846-52.

Gombotz H, Weh B, Mitterndorfer W, Rehak P. In-hospital cardiac resuscitation outside the ICU by nursing staff equipped with automated external defibrillators--the first 500 cases. Resuscitation. 2006 Sep;70(3):416-22. Epub 2006 Aug 14.

Woollard M, Whitfield R, Newcombe RG, Colquhoun M, Vetter N, Chamberlain D. Optimal refresher training intervals for AED and CPR skills: a randomised controlled trial. Resuscitation. 2006 Nov;71(2):237-47. Epub 2006 Sep 28.

Responsible Party:	Baylor College of Medicine ( Joseph Rossano / Cardiology Fellow )
Study ID Numbers:	H - 18876
Study First Received:	March 18, 2008
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00640354
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Automated External Defibrillator
Resuscitation
Pediatric

Study placed in the following topic categories:

Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009