Dysrhythmias During General Anesthesia in Children
This study has been completed.
Sponsor:
Children's Hospital of Philadelphia
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
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Results First Received: April 3, 2009
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Retrospective |
| Condition: |
Arrhythmias, Cardiac |
Participant Flow
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
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
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
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. |
Other Adverse Events
| Children With Dysrhythmia Events During Anesthesia | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 0/0 |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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
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 |