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Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests

Primary Purpose

Pediatric Residents

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated external defibrillator
Manual defibrillator
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Residents focused on measuring Automated External Defibrillator, Resuscitation, Pediatric

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric resident at Baylor College of Medicine

Exclusion Criteria:

  • Not a pediatric resident at Baylor College of Medicine

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Pediatric residents randomized to having an automated external defibrillator

Pediatric residents randomized to having a manual defibrillator

Outcomes

Primary Outcome Measures

Time to defibrillation

Secondary Outcome Measures

Full Information

First Posted
March 18, 2008
Last Updated
November 9, 2020
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00640354
Brief Title
Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Residents
Keywords
Automated External Defibrillator, Resuscitation, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pediatric residents randomized to having an automated external defibrillator
Arm Title
2
Arm Type
Active Comparator
Arm Description
Pediatric residents randomized to having a manual defibrillator
Intervention Type
Device
Intervention Name(s)
Automated external defibrillator
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Manual defibrillator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to defibrillation
Time Frame
Within 5 minutes of the start of the simulated cardiac arrest

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric resident at Baylor College of Medicine Exclusion Criteria: Not a pediatric resident at Baylor College of Medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio R Mott, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16762479
Citation
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.
Results Reference
background
PubMed Identifier
7710153
Citation
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.
Results Reference
background
PubMed Identifier
7710155
Citation
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.
Results Reference
background
PubMed Identifier
16738269
Citation
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.
Results Reference
background
PubMed Identifier
12837882
Citation
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.
Results Reference
background
PubMed Identifier
16321714
Citation
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.
Results Reference
background
PubMed Identifier
8214853
Citation
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.
Results Reference
background
PubMed Identifier
11071670
Citation
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.
Results Reference
background
PubMed Identifier
15312869
Citation
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.
Results Reference
background
PubMed Identifier
16908093
Citation
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.
Results Reference
background
PubMed Identifier
17010497
Citation
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.
Results Reference
background
PubMed Identifier
19167721
Citation
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.
Results Reference
derived

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Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests

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