Dysrhythmias During General Anesthesia in Children

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00715390
First received: July 11, 2008
Last updated: December 13, 2012
Last verified: December 2012
Results First Received: April 3, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Arrhythmias, Cardiac

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We performed a retrospective chart review of anesthetics administered at The Children’s Hospital of Philadelphia from July 1998 through July 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Excluded were patients with known arrhythmias or pro-arrhythmic conditions, patients with congenital heart disease and patients undergoing cardiac surgery or cardiac catheterization.

Reporting Groups
  Description
Children With Dysrhythmia Events During Anesthesia The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.

Participant Flow:   Overall Study
    Children With Dysrhythmia Events During Anesthesia  
STARTED     234 [1]
Eligible     234  
COMPLETED     234 [2]
NOT COMPLETED     0  
[1] 114,209 Anesthetic records were screened to identify 234 records.
[2] These were broken down to different types of dysrhythymia.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Children With Dysrhythmia Events During Anesthesia The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.

Baseline Measures
    Children With Dysrhythmia Events During Anesthesia  
Number of Participants  
[units: participants]
  234  
Age  
[units: participants]
 
<=18 years     234  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     100  
Male     134  
Region of Enrollment  
[units: participants]
 
United States     234  
Children with potential intraoperative dysrhythmias [1]
[units: participants]
  234  
[1] Subjects were identified by flagging charts that included the administration of anti-arrhythmic drugs, significant variation in heart rate or pulse rate, and identification of certain keywords known to be associated with the development of an arrhythmia.



  Outcome Measures

1.  Primary:   Arrhythmias During General Anesthesia in Children   [ Time Frame: July 1998 through July 2004 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ronald Litman, DO
Organization: The Children's Hospital of Philadelphia
phone: 215-590-5091
e-mail: litmanr@email.chop.edu


No publications provided


Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00715390     History of Changes
Other Study ID Numbers: 2004-10-3923
Study First Received: July 11, 2008
Results First Received: April 3, 2009
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board