NCT00640354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

March 18, 2008

Last Update Submit

November 9, 2020

Conditions

Pediatric Residents

Keywords

Automated External DefibrillatorResuscitationPediatric

Outcome Measures

Primary Outcomes (1)

  • Time to defibrillation

    Within 5 minutes of the start of the simulated cardiac arrest

Study Arms (2)

1

EXPERIMENTAL

Pediatric residents randomized to having an automated external defibrillator

Device: Automated external defibrillator

2

ACTIVE COMPARATOR

Pediatric residents randomized to having a manual defibrillator

Device: Manual defibrillator

Interventions

Automated external defibrillatorDEVICE

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

1
Manual defibrillatorDEVICE

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.

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric resident at Baylor College of Medicine

You may not qualify if:

  • Not a pediatric resident at Baylor College of Medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (12)

  • 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. doi: 10.1016/j.resuscitation.2005.10.031. Epub 2006 Jun 8.

    PMID: 16762479BACKGROUND

  • 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. doi: 10.1016/s0196-0644(95)70263-6.

    PMID: 7710153BACKGROUND

  • 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. doi: 10.1016/s0196-0644(95)70265-2.

    PMID: 7710155BACKGROUND

  • 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. doi: 10.1056/NEJMoa052917.

    PMID: 16738269BACKGROUND

  • 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. doi: 10.1542/peds.112.1.163. No abstract available.

    PMID: 12837882BACKGROUND

  • 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. doi: 10.1016/j.resuscitation.2005.10.008. No abstract available.

    PMID: 16321714BACKGROUND

  • 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. doi: 10.1016/s0196-0644(05)81302-2.

    PMID: 8214853BACKGROUND

  • 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. doi: 10.1056/NEJM200010263431701.

    PMID: 11071670BACKGROUND

  • 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. doi: 10.1016/j.jacc.2004.04.054.

    PMID: 15312869BACKGROUND

  • 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. doi: 10.1016/j.resuscitation.2006.02.006. Epub 2006 Aug 14.

    PMID: 16908093BACKGROUND

  • 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. doi: 10.1016/j.resuscitation.2006.04.005. Epub 2006 Sep 28.

    PMID: 17010497BACKGROUND

  • Rossano JW, Jefferson LS, Smith EO, Ward MA, Mott AR. Automated external defibrillators and simulated in-hospital cardiac arrests. J Pediatr. 2009 May;154(5):672-6. doi: 10.1016/j.jpeds.2008.11.051. Epub 2009 Jan 23.

    PMID: 19167721DERIVED

MeSH Terms

Interventions

Defibrillators

Intervention Hierarchy (Ancestors)

ElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Antonio R Mott, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics-Cardiology

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

US(1)