Pediatric ResidentsNCT00640354
Time to Defibrillation Using Automated External Defibrillators by Pediatric Residents in Simulated Cardiac Arrests
A study testing Automated external defibrillator and Manual defibrillator in people with Pediatric Residents, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Residents
- What is being tested?
- Automated external defibrillator and Manual defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric resident at Baylor College of Medicine
Who cannot join
- Not a pediatric resident at Baylor College of Medicine
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Pediatric Residents
- Being tested
- Automated external defibrillator, Manual defibrillator
- Keywords
- Automated External Defibrillator, Resuscitation, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pediatric residents randomized to having an automated external defibrillator Receives: Device: Automated external defibrillator |
| 2 | Active comparator | Pediatric residents randomized to having a manual defibrillator Receives: Device: Manual defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to defibrillation
Measured: Within 5 minutes of the start of the simulated cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pediatric ResidentsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Mott, Baylor College of Medicine
- Investigators
- Antonio R Mott, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640354
- Sponsor's protocol ID
- H - 18876
- Status last verified
- Nov 2020
- First submitted
- 18 Mar 2008
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.resuscitation.2005.10.031. Epub 2006 Jun 8.
PubMed 16762479Mogayzel 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.
PubMed 7710153Hickey 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.
PubMed 7710155Samson 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.
PubMed 16738269Samson 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.
PubMed 12837882Deakin 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.
PubMed 16321714Larsen 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.
PubMed 8214853Valenzuela 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.
PubMed 11071670Zafari 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.
PubMed 15312869Gombotz 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.
PubMed 16908093Woollard 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.
PubMed 17010497Rossano 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.
PubMed 19167721
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00640354
- Acronym / sponsor ID
- H - 18876
- Conditions
- Pediatric Residents
- Keywords
- Automated External Defibrillator, Resuscitation, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Automated external defibrillatorPediatric residents randomized to having an automated external defibrillator |
| 2 | Active comparator | Device: Manual defibrillatorPediatric residents randomized to having a manual defibrillator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric resident at Baylor College of Medicine
Key exclusion criteria (1 listed)
- Not a pediatric resident at Baylor College of Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated external defibrillatorResidents 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 | Device | 1 |
| Manual defibrillatorResidents 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. | Device | 2 |
Primary outcome
Time to defibrillation
Time frame: Within 5 minutes of the start of the simulated cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 16762479Rossano 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.
- Background: PubMed 7710153Mogayzel 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.
- Background: PubMed 7710155Hickey 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.
- Background: PubMed 16738269Samson 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.
- Background: PubMed 12837882Samson 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.
- Background: PubMed 16321714Deakin 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.
- Background: PubMed 8214853Larsen 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.
- Background: PubMed 11071670Valenzuela 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.
- Background: PubMed 15312869Zafari 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.
- Background: PubMed 16908093Gombotz 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.
- Background: PubMed 17010497Woollard 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.
- Derived from this study: PubMed 19167721Rossano 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.
Related trials for Pediatric Residents
Recruiting
Choice and Autonomy in Learning Mindfulness for Pediatric Residents
Program Engagement, Treatment Adherence and Compliance
Recruiting
Femoral Arterial Cannulation in Pediatrics
Pediatric ALL, Cardiac Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio R Mott, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated external defibrillator and Manual defibrillator in people with Pediatric Residents, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to defibrillation (time frame: Within 5 minutes of the start of the simulated cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640354, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.