Congenital DisordersNCT00277966
Cath Lab Performance Improvement
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2004
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January - June, 2004.
Who cannot join
- Those who did not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Cardiac Catheterization Laboratory Radiology Performance Improvement
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.
Read the detailed description
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.
To perform radiological procedures with minimal radiation exposure and to ensure safe care during catheterization procedures, we conducted a chart review of all patients requiring fluoroscopy in the lab during the period of January - June, 2004.
- Based on our Retrospective Review, we were able to present Our New Standards to the Cardiac Cath Lab Committee at the end of June, 2004 with the following:
- Diagnostic procedure time decreased from 45 minutes standard to 30 minutes standard.
- Intervention and Electrophysiology procedure time reduced from 90 minutes to 45 minutes.
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, Cardiac Catheterization, Fluoroscopy time
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJan 2004
- Primary completionJan 2004
- Study completionJan 2004
Why it stopped: No enrollment as this was a retrospective review, not a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Mary Stevens, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277966
- Sponsor's protocol ID
- 05-051
- Status last verified
- Aug 2016
- First submitted
- 13 Jan 2006
- Last updated
- 9 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Catheterization Laboratory Radiology Performance Improvement
- ClinicalTrials.gov ID
- NCT00277966
- Acronym / sponsor ID
- 05-051
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, Cardiac Catheterization, Fluoroscopy time
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment as this was a retrospective review, not a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 18 Jan 2006 (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.
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.
Detailed description
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.
To perform radiological procedures with minimal radiation exposure and to ensure safe care during catheterization procedures, we conducted a chart review of all patients requiring fluoroscopy in the lab during the period of January - June, 2004.
- Based on our Retrospective Review, we were able to present Our New Standards to the Cardiac Cath Lab Committee at the end of June, 2004 with the following:
- Diagnostic procedure time decreased from 45 minutes standard to 30 minutes standard.
- Intervention and Electrophysiology procedure time reduced from 90 minutes to 45 minutes.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January - June, 2004.
Key exclusion criteria (1 listed)
- Those who did not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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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.
Mary Stevens, MD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta 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: withdrawn, as of the sponsor's last update on 9 Aug 2016. 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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 9 Aug 2016.