NCT00715390

Brief Summary

To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 1, 2011

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

July 11, 2008

Results QC Date

April 3, 2009

Last Update Submit

December 13, 2012

Conditions

Keywords

ChildrenCardiac ArrhythmiaGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Arrhythmias During General Anesthesia in Children

    July 1998 through July 2004

Study Arms (1)

1-Children receiving anesthesia

The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who have undergone anesthesia at the Children's Hospital of Philadelphia or at one of CHOP's satellite surgicenters, and whose anesthetic record was recorded electronically into the Compurecord system will be screened.

You may qualify if:

  • Children, while under anesthesia, having
  • circumstances of tachycardia and bradycardia,
  • administration of medications used in the treatment of dysrhythmias,
  • the commentary which includes comment about the heart rhythm or therapy for dysrhythmia,
  • in the quality assurance database for evidence of dysrhythmia

You may not qualify if:

  • Children with a known pre-operative:
  • prior history of dysrhythmia and/or
  • residual congenital heart disease
  • anti/pro dysrhythmic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ronald Litman, DO
Organization
The Children's Hospital of Philadelphia

Study Officials

  • Ronald S Litman, DO

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

October 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2006

Last Updated

December 27, 2012

Results First Posted

March 1, 2011

Record last verified: 2012-12

Locations