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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00640354
Other study ID # H - 18876
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2006
Est. completion date February 2007

Study information

Verified date November 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Pediatric resident at Baylor College of Medicine Exclusion Criteria: - Not a pediatric resident at Baylor College of Medicine

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. Epub 2006 Aug 14. — View 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. Review. — View 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. — View 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. — View 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. Epub 2006 Jun 8. — View 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. — View 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. — View 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. — View 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. Epub 2006 Sep 28. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Time to defibrillation Within 5 minutes of the start of the simulated cardiac arrest
See also
  Status Clinical Trial Phase
Completed NCT03349541 - Paediatric Resident Complex Care Curriculum RCT N/A